FDA recall record · openFDA
Medtronic Inc.
39 FDA recalls on record (2023–2026) — 39 device. 39 still ongoing.
0
Class I (most serious)
39
Class II
0
Class III
39
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing. 23
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the m 3
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, 2
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates t 2
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who ha 1
Recalls
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f Class II 2026-03-11 Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Class II 2025-06-18 Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo Class II 2025-06-17 Azure S DR MRI SureScan, Product number W3DR01 Class II 2025-04-29 Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr Class II 2025-06-18 Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Class II 2025-10-29 Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwar Class II 2025-06-17 Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060 Class II 2025-12-04 EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator Class II 2024-04-16 Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT Class II 2024-07-11 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 Class II 2024-02-16 PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB Class II 2024-04-16 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator Class II 2024-04-16 CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator Class II 2024-04-16 Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator Class II 2024-04-16 COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator Class II 2024-04-16 MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator Class II 2024-04-16 ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor Class II 2023-11-03 Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. Class II 2023-11-20 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 Class II 2023-10-12 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5 Class II 2023-10-12 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 Class II 2023-10-12 Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 Class II 2023-12-07
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.