Recall Z-2531-2024 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
Artivion, Inc
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
| Date | Aug 8, 2024 (initiated May 28, 2024) |
| Status | Open, Classified |
| Reason | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters to their Field Representatives on 5/24/2024 or 5/28/2024 for distribution to the consignees via email or hand delivery. The first date consignees were notified was on 5/28/2024 by their Field Representative. The letter provided the details on the tissue the consignee received, the date it was implanted, and the implanting surgeon. The issue was described and it was pointed out there was no indication the impacted tissues were contaminated and unlikely to pose a health risk to the patient. The letter discussed the testing conducted on each allograft and tha |
| Quantity | 2 valves |
| Distribution | US Nationwide distribution in the states of CA, DC, FL, and NY. |
| 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 |