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Medtronic, Inc. FDA Recalls
67 recalls on file across devices, 3 of them Class I and 64 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial fClass IIMar 11, 2026Ventricular fibrillation (VF) occurred during radiofrequency |
| Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060Class IIDec 4, 2025Stents may be impacted by a Nitinol anomaly which causes a r |
| Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Class IIOct 29, 2025There is a potential for delayed time to high-voltage (HV) t |
| Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Class IIJun 18, 2025In prior SmartSync application versions, the Abort button st |
| Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt CrClass IIJun 18, 2025In prior SmartSync application versions, the Abort button st |
| Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwarClass IIJun 17, 2025A software update for Medtronic CareLink SmartSync Device Ma |
| Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compoClass IIJun 17, 2025A software update for Medtronic CareLink SmartSync Device Ma |
| Azure S DR MRI SureScan, Product number W3DR01Class IIApr 29, 2025Identified devices may experience sudden battery power failu |
| 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTClass IIJul 11, 2024Medtronic CareLink 2090 programmers with serial number prefi |
| COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter DefibrillatorClass IIApr 16, 2024Potential for manufacturing defect. Weld crack led to device |
| Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090Class IIFeb 16, 2024There is a potential for sterile package breach. |
| Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1Class IIDec 7, 2023During internal review of Polaris battery assembly data from |
| Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.Class IINov 20, 2023Seal defects could compromise the ability of the product pac |
| ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac MonitorClass IINov 3, 2023It may create the potential for amplified noise and/or overa |
| Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6Class IIOct 12, 2023The Mo.Ma Ultra device manifold is labelled with 2 stickers, |
| Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6Class IIOct 12, 2023The Mo.Ma Ultra device manifold is labelled with 2 stickers, |
| Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5Class IIOct 12, 2023The Mo.Ma Ultra device manifold is labelled with 2 stickers, |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery SystemClass IIJul 14, 2022Update to IFU provides a manual deployment workaround method |
| Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxiaClass IIJun 24, 2022Luer has balloon diameter printed as "2.25mmx12mm" instead o |
| HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.Class IMay 5, 2022Batteries for the HVAD system have a weld defect affecting i |
| HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PUClass IApr 14, 2022The pump may have a welding defect that can lead the pump to |
| Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) SysClass IIMar 30, 2022Errors and inconsistencies that were identified in the Instr |
| Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation SystClass IMar 2, 2022There is potential for the capsule bond to break during the |
| VenaSeal Closure SystemClass IIIMar 23, 2021Firm received increased number of reports that VenaSeal disp |
| Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in tClass IIMar 16, 2021Incorrect size printed on the device; packaging is labeled c |
| Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 207630002Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GSClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 PrClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 007630002Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 0064316954Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 ProductClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C5 Guardian Sensor (3) for the following packaging: GS3 5PK 1L AUS/ GTIN: 20763000252056 GSClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 2076300019208Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 ProducClass IIFeb 26, 2021Use of the continuous glucose monitoring system while active |
| Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3Class IIFeb 26, 2021Use of the continuous glucose monitoring system while active |