Medtronic Inc.
67 recalls on record · Latest: Dec 10, 2025
FDA Devices Moderate Dec 10, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
FDA Devices Moderate Jul 30, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software M…
FDA Devices Moderate Jul 30, 2025
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Mod…
FDA Devices Moderate Jul 23, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra appl…
FDA Devices Moderate Jul 23, 2025
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Ast…
FDA Devices Moderate Jun 18, 2025
Azure S DR MRI SureScan, Product number W3DR01
FDA Devices Moderate Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Produc…
FDA Devices Moderate Jul 3, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Jul 3, 2024
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
FDA Devices Moderate Mar 27, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
FDA Devices Moderate Jan 10, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
FDA Devices Moderate Dec 20, 2023
Medtronic SynchroMed, Model A10
FDA Devices Moderate Dec 6, 2023
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
FDA Devices Moderate Nov 29, 2023
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
FDA Devices Critical Jun 29, 2022
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
FDA Devices Critical Jun 15, 2022
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
FDA Devices Critical Apr 27, 2022
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN:…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 007630003…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 0076300…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 2076300033…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 0076300024…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 007630003…
FDA Devices Moderate May 26, 2021
Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intende…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020GA, Guardian Sensor (3) for the following packaging: GS3 5PK US GC/ GTIN: 20763000179629 Product Usage: intended for use…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with…
FDA Devices Moderate May 26, 2021
Medtronic REF: MMT-7020C4 Guardian Sensor (3) for the following packaging: GS3 5PK 2L CANADA/ GTIN: 20763000179612 Product Usage: intended for…
FDA Devices Moderate Jan 20, 2021
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software U…
FDA Devices Moderate Dec 9, 2020
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glu…
FDA Devices Moderate Sep 23, 2020
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
FDA Devices Moderate Jun 10, 2020
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
FDA Devices Critical Feb 19, 2020
Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
FDA Devices Critical Feb 19, 2020
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 US Distribut…
FDA Devices Critical Feb 19, 2020