Merit Medical
MMSI NASDAQ
Medicare add-on payments
- New
- 0
- Continued
- 1
- Lost
- 0
| Status | Technology | Max add-on payment | Implied cost per case |
|---|---|---|---|
| Continued | Merit Wrapsody Cell Impermeable Endoprosthesis (CIE) | $3,770 | $5,800 |
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 FDA data may be out of date.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 | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D,…+4 more products | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future… | Feb 13, 2026 | FDA record |
| Class II | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes:… | Due to unsealed portions of pouches. | May 8, 2026 | FDA record |
| Class II | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY+2 more products | catheter may experience resistance when being advanced over the guidewire | Apr 2, 2026 | FDA record |
| Class II | Allwell Inflation Device, for angiographic use REF: IS-30-A+6 more products | Inflation device handle may detach from the syringe during procedure. | Dec 4, 2025 | FDA record |
| Class II | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B,… | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage. | Aug 4, 2025 | FDA record |
| Class II | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore… | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. | Jul 25, 2025 | FDA record |
| Class II | Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548,…+3 more products | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | Jun 5, 2025 | FDA record |
| Class II | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly+1 more products | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. | Mar 14, 2025 | FDA record |
| Class II | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. | Jan 27, 2025 | FDA record |
| Class II | Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to…+5 more products | Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier. | Aug 30, 2024 | FDA record |
| Class II | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C+9 more products | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. | Aug 19, 2024 | FDA record |
| Class II | Custom Procedure Kit, REF: K12T-11077+1 more products | 7F sheath introducers labeled as 7.5F | Aug 12, 2024 | FDA record |
| Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management…+22 more products | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | Jun 11, 2024 | FDA record |
| Class II | Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP… | Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the… | May 22, 2024 | FDA record |
| Class II | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY+1 more products | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Mar 14, 2024 | FDA record |
| Class II | Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B,…+2 more products | The sterility of microcatheter and infusion system devices cannot be guaranteed. | Nov 6, 2023 | FDA record |