Recall Z-1533-2020 ยท LWQ Heart-Valve, Mechanical
MEDTRONIC ATS MEDICAL, INC.
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
| Date | Feb 11, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | On 11-Feb-2020, a Medtronic field representative notified the 1 (one) consignee who had received affected product via telephone. The consignee was asked to quarantine and return the affected product. |
| Quantity | 2 devices |
| Distribution | China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.