Z-1524-2008

CryoValve, Pulmonary Valve & Conduit

Name: Z-1524-2008 CryoValve, Pulmonary Valve & Conduit
Creator: CryoLife, Inc.
Published: 2008-03-26
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2008-03-26 / Terminated / root cause: manufacturing process

FDA source

CryoLife, Inc. began a recall of CryoValve, Pulmonary Valve & Conduit on 2008-03-26. The reason FDA records is "Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1524-2008
Status: Terminated
Initiated: 2008-03-26
Posted: 2008-09-01
Terminated: 2010-01-12
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Valve & Conduit
Product code: MIE Heart-Valve, Allograft
Reason for recall: Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
Quantity in commerce: 1 tissue
Distribution: Hospitals in DE, TN
Product codes and lots: Donor number 87732, Serial number 8895391

Product code MIE

K033484UnclassifiedHuman Heart Valve, Cryovalve SgCryolife, Inc. / cleared 2008-02-07

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)