FDA Device recall Z-1533-2020
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm by Medtronic Ats Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1533-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-11 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Ats Medical |
| Distribution | n/a |
Product
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Reason
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.
Identifiers
| code_info | UDI 00643169297913, Serial Numbers: 935603, 935732 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2020%22
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