Abbott
ABT NYSE
Medicare add-on payments
- New
- 0
- Continued
- 2
- Lost
- 2
| Status | Technology | Max add-on payment | Implied cost per case |
|---|---|---|---|
| Continued | Esprit BTK Everolimus Eluting Resorbable Scaffold System | $6,923 | $10,650 |
| Continued | TriClip G4 | $26,000 | $40,000 |
| Lost | Aveir AR Leadless Pacemaker | $10,725prior-year maximum | $16,500 |
| Lost | Aveir Leadless Pacemaker (Dual-Chamber) | $15,600prior-year maximum | $24,000 |
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 FDA data may be out of date.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 | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous…+3 more products | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results | Nov 24, 2025 | FDA record |
| Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter+4 more products | Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. | Sep 10, 2025 | FDA record |
| Class I | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The…+1 more products | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect. | Jun 23, 2025 | FDA record |
| Class I | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left… | Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External… | Mar 13, 2025 | FDA record |
| Class I | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on… | Jul 24, 2024 | FDA record |
| Class I | Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left… | System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to… | May 8, 2024 | FDA record |
| Class I | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly+1 more products | Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. | Mar 1, 2024 | FDA record |
| Class I | HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2.…+1 more products | Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. | Feb 19, 2024 | FDA record |
| Class I | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication… | Due to software and controller systems that results in unexpected pump start or pump stop. | Jan 3, 2024 | FDA record |
| Class II | Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The…+2 more products | Due to 11 volt Backup Battery failures. | May 13, 2026 | FDA record |
| Class II | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. | May 12, 2026 | FDA record |
| Class II | i-STAT G3+ cartridge; List Number: 03P78-26;+2 more products | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and… | Apr 1, 2026 | FDA record |
| Class II | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus… | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. | Feb 9, 2026 | FDA record |
| Class II | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software… | Nov 13, 2025 | FDA record |
| Class II | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00;… | Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump… | Oct 10, 2025 | FDA record |
| Class II | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT,…+3 more products | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. | Oct 9, 2025 | FDA record |
| Class II | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400+1 more products | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may… | Oct 6, 2025 | FDA record |
| Class II | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and… | Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. | Sep 18, 2025 | FDA record |
| Class II | i-STAT CG4+ cartridge (white). List Number: 03P85-25. | Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2. | Aug 21, 2025 | FDA record |
| Class II | i-STAT EG6+ cartridge. List Number: 03P77-25.+2 more products | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2. | Aug 21, 2025 | FDA record |
| Class II | Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot… | Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as… | May 21, 2025 | FDA record |
| Class II | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended…+1 more products | There were reports of an increase in reactive negative controls and false positive results. | Apr 28, 2025 | FDA record |
| Class II | The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and… | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the… | Mar 20, 2025 | FDA record |
| Class II | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description:…+4 more products | When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of… | Mar 18, 2025 | FDA record |
| Class II | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080+1 more products | Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air… | Mar 17, 2025 | FDA record |
| Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product…+2 more products | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Mar 4, 2025 | FDA record |
| Class II | Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Product…+2 more products | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | Mar 4, 2025 | FDA record |
| Class II | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir… | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. | Feb 15, 2025 | FDA record |
| Class II | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000… | Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is… | Feb 3, 2025 | FDA record |
| Class II | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the… | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to… | Nov 21, 2024 | FDA record |
| Class II | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100)… | Due to a data migration from on-premises server to the cloud environment, some customers reported that they were not able to transmit readings. | Nov 6, 2024 | FDA record |
| Class II | 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.+3 more products | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. | Nov 6, 2024 | FDA record |
| Class II | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile+4 more products | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve… | Oct 17, 2024 | FDA record |
| Class II | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN)…+1 more products | As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings. | Oct 5, 2024 | FDA record |
| Class II | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091+1 more products | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced… | Sep 12, 2024 | FDA record |
| Class II | HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed… | Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result… | Jun 25, 2024 | FDA record |
| Class II | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results. | Jun 17, 2024 | FDA record |
| Class II | Alinity hq Analyzer, REF: 09P68-01 | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell… | Jun 14, 2024 | FDA record |
| Class II | 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the… | Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm,… | May 22, 2024 | FDA record |
| Class II | Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only+3 more products | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. | May 22, 2024 | FDA record |
| Class II | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY | Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may… | May 16, 2024 | FDA record |
| Class II | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only+11 more products | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | May 16, 2024 | FDA record |
| Class II | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer sheath. | Apr 30, 2024 | FDA record |
| Class II | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has… | Mar 20, 2024 | FDA record |
| Class II | ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35+1 more products | Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below… | Mar 4, 2024 | FDA record |
| Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock… | Mar 1, 2024 | FDA record |
| Class II | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial… | Feb 21, 2024 | FDA record |
| Class II | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. | Feb 5, 2024 | FDA record |
| Class II | TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile. | When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to… | Dec 18, 2023 | FDA record |
| Class II | Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase… | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. | Oct 30, 2023 | FDA record |
| Class II | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter,… | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | Oct 19, 2023 | FDA record |
| Class II | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous…+2 more products | The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). | Oct 19, 2023 | FDA record |
| Class III | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device…+1 more products | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download. | Oct 1, 2024 | FDA record |
| Class III | Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)+2 more products | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | Feb 1, 2024 | FDA record |