Evolut — Class II medical device recall Z-0561-2021
Terminated recall by Medtronic Heart Valves Division, reported 2020-12-16, distributed nationwide. Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatatio
| Recall number | Z-0561-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Heart Valves Division, Santa Ana, CA, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-12-10 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2022-11-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CO, DE, DK, EG, ES, FI, GB, HU, IE, IN, IT, JP, LU, MX, NO, PA, PL, PT, SA, SE |
| Quantity | 19,961 units |
| Model numbers | EVPROPLUS-23US |
Product
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA.
Reason for recall
Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0561-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.