Recall Z-1545-2024 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
Artivion, Inc
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
| Date | Apr 16, 2024 (initiated Mar 6, 2024) |
| Status | Open, Classified |
| Reason | The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus. |
| Root cause | Under Investigation by firm |
| Action | The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) Cryolife, Inc., May 25, 2010 |