Recall Z-0722-03 ยท LMO
Cryolife Inc
CryoValve Heart-valve, allograft
| Date | Apr 15, 2003 (initiated Mar 19, 2003) |
| Status | Terminated |
| Reason | The recipient of one of the kidneys from the donor has developed renal cell carcinoma. |
| Root cause | Other |
| Action | Implanting physicians were notified by letter on 3/19/2003. Since CryoLife has been notified that the allografts have been implanted, the notification is intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. They were advised to complete an enclosed, stamped, self-addressed postcard to affirm receipt of the notification. |
| Quantity | There are two individual heart valve allografts. |
| Distribution | Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.