Medtronic Heart Valves Division recalls

Medtronic Heart Valves Division has 7 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 8 Jul 2026. 4 are still ongoing. 1 was reported in the last 12 months.

Total recalls7since 2020

Last 12 months1reported

Class I114% of total

Ongoing4latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 1 14%Class II 6 86%Class III 0 0%

Why medtronic heart valves division is recalled

Other Reasons686%
Sterility114%

Product types

Heart & Vascular Devices457%
Other Medical Devices343%

By year

2026114%
2021343%
2020343%

Ongoing medtronic heart valves division recalls

4 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS I	Medtronic Harmony Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	Nationwide
14 Jul 2021Device	CLASS II	CoreValve Evolut PRO PLUS Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states
14 Jul 2021Device	CLASS II	CoreValve Evolut R Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states
14 Jul 2021Device	CLASS II	CoreValve Evolut PRO Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states

All medtronic heart valves division recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS I	Medtronic Harmony Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	Nationwide
14 Jul 2021Device	CLASS II	CoreValve Evolut PRO PLUS Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states
14 Jul 2021Device	CLASS II	CoreValve Evolut R Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states
14 Jul 2021Device	CLASS II	CoreValve Evolut PRO Delivery Catheter System recalled	Medtronic Heart Valves Division	Other	48 states
16 Dec 2020Device	CLASS II	Evolut (TM) R System recalled by Medtronic Heart Valves	Medtronic Heart Valves Division	Sterility	Nationwide
16 Dec 2020Device	CLASS II	Evolut (TM) PRO+ System recalled by Medtronic Heart Valves	Medtronic Heart Valves Division	Other	Nationwide
16 Dec 2020Device	CLASS II	Evolut (TM) PRO System recalled by Medtronic Heart Valves	Medtronic Heart Valves Division	Other	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.