CryoValve Heart-valve, allograft
FDA device recall Z-0723-03 · posted 2003-04-15 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LMO
- Quantity affected
- There are two individual heart valve allografts.
- Distribution
- Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.
- Date initiated
- 2003-03-19
- Date posted
- 2003-04-15
- Date terminated
- 2003-05-05
- Location
- Kennesaw, GA
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