Brand

Medtronic Inc. Recalls

62 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Medtronic Inc..

62Total Recalls
8Critical
3.3MUnits Affected
Mar 11, 2026Most Recent
All Recalls

Every Medtronic Inc. Recall

Sorted by most recent. Click any recall for full details.

62 recalls
High RiskFDA
Medtronic, Inc.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Cardiac Devices·77,510 affected·Mar 11, 2026
High RiskFDA
Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Medical Implants·6,591 affected·Oct 29, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, ...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Medtronic, Inc.
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azur...
Medical Devices·3,909 affected·Jun 17, 2025
High RiskFDA
Medtronic, Inc.
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: ...
Medical Devices·5,418 affected·Jun 17, 2025
High RiskFDA
Medtronic, Inc.
Azure S DR MRI SureScan, Product number W3DR01
Medical Devices·6 affected·Apr 29, 2025
High RiskFDA
Medtronic Inc.
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 20...
Medical Devices·18,788 affected·Jul 11, 2024
High RiskFDA
Medtronic Inc.
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Medical Implants·14 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·5 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Medical Implants·8 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Medical Implants·13 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·36 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Medical Implants·9 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Medical Implants·26 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Medical Implants·4 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Medical Implants·2 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Medical Implants·6 affected·Apr 16, 2024
High RiskFDA
Medtronic Inc.
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Medical Implants·65 affected·Feb 16, 2024
High RiskFDA
Medtronic Inc.
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Medical Implants·1 affected·Nov 20, 2023
High RiskFDA
Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Cardiac Devices·64,739 affected·Nov 3, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medical Devices·173 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medical Devices·48 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Medical Devices·2,767 affected·Oct 12, 2023
CriticalFDA
Medtronic Inc
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Cardiac Devices·429 affected·May 5, 2022
CriticalFDA
Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Medical Implants·21 affected·Apr 14, 2022
CriticalFDA
Medtronic Inc
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medical Implants·1,483 affected·Mar 2, 2022
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW G...
Diabetes Devices·497,747 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN...
Diabetes Devices·302,667 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ G...
Diabetes Devices·15,162 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTI...
Diabetes Devices·15,393 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN:...
Diabetes Devices·1,224,032 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN...
Diabetes Devices·111,678 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTI...
Diabetes Devices·13,014 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Us...
Diabetes Devices·1,174 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: ...
Diabetes Devices·12,624 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: inte...
Diabetes Devices·1,863 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended ...
Diabetes Devices·5,571 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: ...
Diabetes Devices·54,211 affected·Feb 26, 2021
High RiskFDA
Medtronic Inc.
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes ...
Diabetes Devices·46,461 affected·Nov 12, 2020
High RiskFDA
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medical Devices·3,588 affected·Jul 15, 2020
High RiskFDA
Medtronic Inc.
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monit...
Diabetes Devices·391 affected·Apr 30, 2020
CriticalFDA
Medtronic Inc.
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Medical Implants·24 affected·Apr 10, 2020
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version ...
Medical Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for ...
Diabetes Devices·0 affected·Nov 21, 2019
CriticalFDA
Medtronic Inc.
Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
Diabetes Devices·0 affected·Nov 21, 2019