Z-0675-03

CryoValve Allograft heart valve

Name: Z-0675-03 CryoValve Allograft heart valve
Creator: Cryolife Inc
Published: 2003-01-23
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-01-23 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Allograft heart valve on 2003-01-23. The reason FDA records is "An allograft associated with this donor has been linked to an alleged infection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0675-03
Status: Terminated
Initiated: 2003-01-23
Posted: 2003-03-21
Terminated: 2004-03-22
Recalling firm: Artivion, Inc.
Product: CryoValve Allograft heart valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: An allograft associated with this donor has been linked to an alleged infection.
FDA root cause: Other
Action: A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction
Quantity in commerce: 1 unit
Distribution: The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
Product codes and lots: Model number SGPV00, Serial Number: 7291867, Donor #55899

Product code MIE

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)