Medtronic Heart Valves Division
Santa Ana, CA
This page shows every FDA and USDA recall linked to Medtronic Heart Valves Division. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
6
Total Recalls
2020
First Recall
2021
Most Recent
CoreValve Evolut PRO PLUS Delivery Catheter System,
REF:
D-EVPROP2329US;
D-EVPROP34US;
Jun 11, 2021
· Device
Open, Classified
CoreValve Evolut R Delivery Catheter System,
REF:
ENVEOR-L;
ENVEOR-N;
Jun 11, 2021
· Device
Open, Classified
CoreValve Evolut PRO Delivery Catheter System,
REF:
ENVPRO-14;
ENVPRO-16;
Jun 11, 2021
· Device
Open, Classified
Evolut (TM) PRO+ System. With the following model numbers:
a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-2...
Oct 23, 2020
· Device
Terminated
Evolut (TM) R System. With the following model numbers:
a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6...
Oct 23, 2020
· Device
Terminated
Evolut (TM) PRO System. With the following model numbers:
a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23...
Oct 23, 2020
· Device
Terminated