Medtronic
MDT NYSE
Medicare add-on payments
- New
- 2
- Continued
- 2
- Lost
- 0
| Status | Technology | Max add-on payment | Implied cost per case |
|---|---|---|---|
| New | Infuse Bone Graft | $4,397 | $6,764 |
| New | OmniaSecure MRI SureScan Lead Model 3930M | $7,797 | $11,995 |
| Continued | PulseSelect Pulsed Field Ablation (PFA) Loop Catheter | $6,338 | $9,750 |
| Continued | Symplicity Spyral Multi-Electrode Renal Denervation Catheter | $10,400 | $16,000 |
FDA device recalls, last 36 months
FDA data as of . Source: openFDA. FDA data may be out of date.
| Class | Product | Reason | Initiated | FDA record |
|---|---|---|---|---|
| Class I | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach… | Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus,… | Aug 6, 2026 | FDA record |
| Class I | Medtronic Harmony Delivery Catheter System | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue. | May 22, 2026 | FDA record |
| Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110+2 more products | The catheters may not retain their shape. | Aug 6, 2025 | FDA record |
| Class I | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance,… | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from… | Jun 3, 2025 | FDA record |
| Class I | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus… | Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert… | May 21, 2025 | FDA record |
| Class I | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract… | Feb 26, 2025 | FDA record |
| Class I | Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no.… | Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and… | Feb 5, 2025 | FDA record |
| Class I | Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20,…+1 more products | Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically… | Jan 30, 2025 | FDA record |
| Class I | Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666…+1 more products | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). | Nov 1, 2024 | FDA record |
| Class I | MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;…+2 more products | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the… | Jul 31, 2024 | FDA record |
| Class I | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only+1 more products | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. | Jul 9, 2024 | FDA record |
| Class I | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,… | Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of… | Jun 24, 2024 | FDA record |
| Class I | NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve… | Potential for false negative response on the NIM Vital Nerve Monitoring System | Jun 24, 2024 | FDA record |
| Class I | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical… | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. | Mar 26, 2024 | FDA record |
| Class I | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. | Mar 25, 2024 | FDA record |
| Class I | AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.+2 more products | The failure to detect the partial obstruction in a 2.5mm sensor. | Mar 21, 2024 | FDA record |
| Class I | Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid…+4 more products | Potential for catheter disconnection from the patient line stopcock connectors. | Jan 22, 2024 | FDA record |
| Class II | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722+5 more products | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction. | Jun 24, 2026 | FDA record |
| Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY PASS FINAL BOX07405V1 BOX BYPASS CARDON BOX01056V2 BOX…+4 more products | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery. | Jun 24, 2026 | FDA record |
| Class II | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin… | Jun 17, 2026 | FDA record |
| Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter+1 more products | Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants. | Jun 8, 2026 | FDA record |
| Class II | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula+1 more products | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | May 25, 2026 | FDA record |
| Class II | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. | May 19, 2026 | FDA record |
| Class II | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor+1 more products | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | May 13, 2026 | FDA record |
| Class II | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096… | The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. | May 13, 2026 | FDA record |
| Class II | Octopus Evolution AS Tissue Stabilizer, Model TS2500+2 more products | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary… | May 12, 2026 | FDA record |
| Class II | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable… | Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. | Apr 23, 2026 | FDA record |
| Class II | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050+2 more products | Temperature probe devices lack FDA clearance. | Apr 23, 2026 | FDA record |
| Class II | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter+8 more products | Certain lots of product have the potential for a sterile barrier breach. | Apr 21, 2026 | FDA record |
| Class II | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing… | Due to customer complaint regarding incorrect display box labeling. | Apr 15, 2026 | FDA record |
| Class II | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; | The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure. | Apr 15, 2026 | FDA record |
| Class II | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN… | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be… | Apr 8, 2026 | FDA record |
| Class II | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. | Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization… | Mar 11, 2026 | FDA record |
| Class II | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)+13 more products | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site,… | Feb 13, 2026 | FDA record |
| Class II | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital… | Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system. | Jan 30, 2026 | FDA record |
| Class II | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to… | Jan 30, 2026 | FDA record |
| Class II | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the… | Jan 13, 2026 | FDA record |
| Class II | Mazor X robotic guidance system REF: TPL0059 | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. | Dec 10, 2025 | FDA record |
| Class II | Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090… | Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration. | Dec 4, 2025 | FDA record |
| Class II | A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on… | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. | Dec 3, 2025 | FDA record |
| Class II | Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B… | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution… | Nov 20, 2025 | FDA record |
| Class II | InPen App, Model/CFN Number: MMT-8061 (Android Users) | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and… | Nov 13, 2025 | FDA record |
| Class II | MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by… | A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. | Nov 2, 2025 | FDA record |
| Class II | Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 | There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur. | Oct 29, 2025 | FDA record |
| Class II | Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174+1 more products | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. | Oct 29, 2025 | FDA record |
| Class II | CareLink Clinic, REF: MMT-7350 | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to… | Oct 21, 2025 | FDA record |
| Class II | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. | Oct 20, 2025 | FDA record |
| Class II | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two… | Oct 3, 2025 | FDA record |
| Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;+1 more products | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion. | Sep 25, 2025 | FDA record |
| Class II | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model… | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate… | Sep 16, 2025 | FDA record |
| Class II | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. | Sep 12, 2025 | FDA record |
| Class II | IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving… | Due to out of the box wobble of the driver. | Jul 17, 2025 | FDA record |
| Class II | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J,… | Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't… | Jun 23, 2025 | FDA record |
| Class II | Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software…+1 more products | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a… | Jun 18, 2025 | FDA record |
| Class II | Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra…+1 more products | A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device… | Jun 17, 2025 | FDA record |
| Class II | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact… | Jun 16, 2025 | FDA record |
| Class II | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. | May 27, 2025 | FDA record |
| Class II | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. | May 7, 2025 | FDA record |
| Class II | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or… | Apr 29, 2025 | FDA record |
| Class II | Enhanced Verify Evaluation Handset (CFN HH90130FA) | Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will… | Apr 3, 2025 | FDA record |
| Class II | NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT… | Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention. | Mar 10, 2025 | FDA record |
| Class II | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA | Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen.… | Mar 4, 2025 | FDA record |
| Class II | Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118)… | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. | Mar 4, 2025 | FDA record |
| Class II | Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 -…+9 more products | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g.… | Feb 17, 2025 | FDA record |
| Class II | MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)+11 more products | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing.… | Jan 31, 2025 | FDA record |
| Class II | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System. | Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump. | Jan 9, 2025 | FDA record |
| Class II | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)+2 more products | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | Dec 12, 2024 | FDA record |
| Class II | Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference… | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. | Dec 4, 2024 | FDA record |
| Class II | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within… | Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following:… | Dec 3, 2024 | FDA record |
| Class II | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version…+3 more products | Software issues were identified in application version 2.x. | Nov 21, 2024 | FDA record |
| Class II | Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal | Oct 3, 2024 | FDA record |
| Class II | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. | A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear. | Sep 24, 2024 | FDA record |
| Class II | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN… | Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | Sep 19, 2024 | FDA record |
| Class II | Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable… | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. | Sep 18, 2024 | FDA record |
| Class II | SynchroMed II Infusion Pump. Product Number: 8637-20 | Potential for error and inability to interrogate pump due to data corruption in the pump memory. | Sep 11, 2024 | FDA record |
| Class II | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an… | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree… | Aug 22, 2024 | FDA record |
| Class II | Vanta Implantable Neurostimulator (INS), Model 977006 | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements. | Aug 21, 2024 | FDA record |
| Class II | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen. | Jul 17, 2024 | FDA record |
| Class II | 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product… | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher. | Jul 11, 2024 | FDA record |
| Class II | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly | IFU update to address device's battery handling information. | Jul 9, 2024 | FDA record |
| Class II | Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 | During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312). | Jul 9, 2024 | FDA record |
| Class II | Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 | Product was distributed past expiration date. | Jul 5, 2024 | FDA record |
| Class II | Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90… | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. | Jun 17, 2024 | FDA record |
| Class II | TourniKwik Tourniquet Set (CFN 79012) | Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. | May 16, 2024 | FDA record |
| Class II | A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and… | Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility. | May 15, 2024 | FDA record |
| Class II | Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit) | Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter… | May 10, 2024 | FDA record |
| Class II | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000 | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery… | Apr 26, 2024 | FDA record |
| Class II | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms. | Apr 25, 2024 | FDA record |
| Class II | EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator+22 more products | Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. | Apr 16, 2024 | FDA record |
| Class II | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection… | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery | Apr 15, 2024 | FDA record |
| Class II | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator | inability to reprogram one device | Mar 28, 2024 | FDA record |
| Class II | Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000+12 more products | Potential for unsealed sterile packing. | Mar 19, 2024 | FDA record |
| Class II | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac…+1 more products | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating | Mar 15, 2024 | FDA record |
| Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT+6 more products | The potential for trocar seal disengagement when using mesh products incorrectly with the device. | Feb 28, 2024 | FDA record |
| Class II | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF… | Feb 21, 2024 | FDA record |
| Class II | Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 | There is a potential for sterile package breach. | Feb 16, 2024 | FDA record |
| Class II | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT+1 more products | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to… | Feb 14, 2024 | FDA record |
| Class II | Medtronic DLP Vessel Cannula, Model Number REF 30000 | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. | Feb 7, 2024 | FDA record |
| Class II | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use… | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage,… | Jan 25, 2024 | FDA record |
| Class II | The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid…+1 more products | European version of microcatheter were distributed within US which contain a different "Indications for Use". | Jan 11, 2024 | FDA record |
| Class II | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC+1 more products | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | Jan 9, 2024 | FDA record |
| Class II | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK…+1 more products | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and… | Dec 21, 2023 | FDA record |
| Class II | Model A710 Intellis Clinician Programmer Application, version 2.0.97 | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to… | Dec 19, 2023 | FDA record |
| Class II | Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 | During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not… | Dec 7, 2023 | FDA record |
| Class II | Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS+1 more products | Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. | Nov 28, 2023 | FDA record |
| Class II | Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. | Seal defects could compromise the ability of the product packaging to maintain sterility. | Nov 20, 2023 | FDA record |
| Class II | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD | Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable | Nov 16, 2023 | FDA record |
| Class II | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally… | Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility | Nov 16, 2023 | FDA record |
| Class II | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2,… | Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor… | Nov 15, 2023 | FDA record |
| Class II | Medtronic SynchroMed II, Model 8637-20, Programmable pump+1 more products | Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving… | Nov 13, 2023 | FDA record |
| Class II | NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736,… | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, | Nov 7, 2023 | FDA record |
| Class II | ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor | It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device… | Nov 3, 2023 | FDA record |
| Class II | PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103+8 more products | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting… | Oct 31, 2023 | FDA record |
| Class II | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators | Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. | Oct 19, 2023 | FDA record |
| Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6+2 more products | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal… | Oct 12, 2023 | FDA record |