Medtronic Open Pivot Aortic Valve Graft — Class II medical device recall Z-1533-2020
Terminated recall by MEDTRONIC ATS MEDICAL, INC., reported 2020-04-01. Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled
| Recall number | Z-1533-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDTRONIC ATS MEDICAL, INC., Plymouth, MN, United States |
| Recall initiated | 2020-02-11 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2022-03-04 |
| Countries outside the US | CN |
| Quantity | 2 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00643169297913 |
| Serial numbers | 935603, 935732 |
| Model numbers | 502AG25 |
Product
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Reason for recall
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
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-1533-2020. 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.