FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Heart-valve, allograft
- Recall number
- Z-0723-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Heart-valve, allograft
- Status
- Terminated
- Initiated
- 2003-03-19
- Posted
- 2003-04-15
- Terminated
- 2003-05-05
- 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.
- Lot, serial or model codes
- Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LMO
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28