CryoValve Heart-valve, allograft
Hazard
The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
What You Should Do
Remedy
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.
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Products
CryoValve Heart-valve, allograft
- Brand
- Cryolife Inc
- UPC
- Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.
Units Affected
There are two individual heart valve allografts.