Z-0723-03

CryoValve Heart-valve, allograft

Name: Z-0723-03 CryoValve Heart-valve, allograft
Creator: Cryolife Inc
Published: 2003-03-19
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-03-19 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Heart-valve, allograft on 2003-03-19. The reason FDA records is "The recipient of one of the kidneys from the donor has developed renal cell carcinoma". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0723-03
Status: Terminated
Initiated: 2003-03-19
Posted: 2003-04-15
Terminated: 2003-05-05
Recalling firm: Artivion, Inc.
Product: CryoValve Heart-valve, allograft
Product code: LMO
Reason for recall: The recipient of one of the kidneys from the donor has developed renal cell carcinoma.
FDA 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 in commerce: There are two individual heart valve allografts.
Distribution: Allografts were distributed to 2 physicians in NY and MS. Allografts were implanted.
Product codes and lots: Aortic Valve & Conduit, Donor #34695, Serial #6356206, Model #AV00 and Pulmonary Valve & Conduit, Donor #34695, Serial #6356214, Model #PV00.

Product code LMO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)