Medtronic recalls

Medtronic appears in 157 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-06.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Medtronic Sphere-9 Catheter, Model Number AFR-00001
  FDA Device · Class II · 2026-05-06 · Medtronic
• Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14…
  FDA Device · Class II · 2026-01-21 · Medtronic
• Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
  FDA Device · Class II · 2025-12-10 · Medtronic
• Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Softw…
  FDA Device · Class II · 2025-07-30 · Medtronic
• Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Sof…
  FDA Device · Class II · 2025-07-30 · Medtronic
• Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Ast…
  FDA Device · Class II · 2025-07-23 · Medtronic
• Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Az…
  FDA Device · Class II · 2025-07-23 · Medtronic
• Azure S DR MRI SureScan, Product number W3DR01
  FDA Device · Class II · 2025-06-18 · Medtronic
• 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM
  FDA Device · Class II · 2024-09-25 · Medtronic
• Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-…
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
  FDA Device · Class II · 2024-07-03 · Medtronic
• Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090
  FDA Device · Class II · 2024-03-27 · Medtronic
• Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
  FDA Device · Class II · 2024-01-31 · Medtronic
• Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile
  FDA Device · Class II · 2024-01-10 · Medtronic
• Medtronic SynchroMed, Model A10
  FDA Device · Class II · 2023-12-20 · Medtronic
• ICM LNQ22 LINQ II, Model LNQ22
  FDA Device · Class II · 2023-12-06 · Medtronic
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
  FDA Device · Class II · 2023-11-29 · Medtronic
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
  FDA Device · Class II · 2023-11-29 · Medtronic
• Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
  FDA Device · Class II · 2023-11-29 · Medtronic
• EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
  FDA Device · Class II · 2022-09-07 · Medtronic
• Medline Sprinter OTW, Model/Catalog Number SPR2512W
  FDA Device · Class II · 2022-08-10 · Medtronic
• HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System
  FDA Device · Class I · 2022-06-29 · Medtronic
• HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
  FDA Device · Class I · 2022-06-15 · Medtronic
• Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System
  FDA Device · Class II · 2022-05-25 · Medtronic
• Harmony Delivery Catheter System
  FDA Device · Class I · 2022-04-27 · Medtronic
• Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 007…
  FDA Device · Class II · 2021-05-26 · Medtronic
• Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended…
  FDA Device · Class II · 2021-05-26 · Medtronic
• Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000…
  FDA Device · Class II · 2021-05-26 · Medtronic
• Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: i…
  FDA Device · Class II · 2021-05-26 · Medtronic