Medtronic recalls

Medtronic has 148 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 6 May 2026. 77 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls148since 2015

Last 12 months2reported

Class I117% of total

Ongoing77latest 6 May 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 1 4 0Aug 0 0 0Nov 0 1 0Feb 0 0 1May 0 0 0Aug 0 0

Severity split

Class I 11 7%Class II 136 92%Class III 1 1%

Why medtronic is recalled

Product types

By year

202621%
202553%
20242718%
202343%
202264%
20212316%
2020117%
201985%
201843%
20171913%

Ongoing medtronic recalls

77 active

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	Sphere-9 Catheter recalled by Medtronic	Medtronic	Other	MN
21 Jan 2026Device	CLASS II	Abre Venous Self-Expanding Stent System recalled by Medtronic	Medtronic	Other	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Device Manager recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Patient Connector recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Medtronic SmartLink software loaded on CareLink SmartSync Device recalled	Medtronic	Device Malfunction	MN
23 Jul 2025Device	CLASS II	Medtronic SmartLink Software loaded on SmartSync Patient Connector recalled	Medtronic	Device Malfunction	MN

All medtronic recalls, newest first

148 total

Reported	Class	Recall	Company	Reason	Where
6 May 2026Device	CLASS II	Sphere-9 Catheter recalled by Medtronic	Medtronic	Other	MN
21 Jan 2026Device	CLASS II	Abre Venous Self-Expanding Stent System recalled by Medtronic	Medtronic	Other	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Device Manager recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
30 Jul 2025Device	CLASS II	CareLink SmartSync Patient Connector recalled by Medtronic	Medtronic	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Medtronic SmartLink software loaded on CareLink SmartSync Device recalled	Medtronic	Device Malfunction	MN
23 Jul 2025Device	CLASS II	Medtronic SmartLink Software loaded on SmartSync Patient Connector recalled	Medtronic	Device Malfunction	MN
18 Jun 2025Device	CLASS II	Azure S DR MRI SureScan, Product number W3DR01 recalled by Medtronic	Medtronic	Device Malfunction	MN
25 Sep 2024Device	CLASS II	Prgm 2090 Programmer-portable Crm recalled by Medtronic	Medtronic	Device Malfunction	MN
3 Jul 2024Device	CLASS II	Evera MRI S DR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Mirro MRI DR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT HF Quad Crt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Primo MRI VR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Evera MRI S DR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT HF Cdt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Crome HF Quad Crt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT HF Quad Crt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Product products recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Evera S VR recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT HF Crt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Mirro MRI VR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Primo MRI DR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt VR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Mirro MRI DR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Crome VR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt DR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Mirro MRI VR SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT VR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt XT DR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt HF Quad Crt-d MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide
3 Jul 2024Device	CLASS II	Cobalt DR MRI SureScan recalled by Medtronic	Medtronic	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.