Z-0167-04

CryoValve Pulmonary Valve & Conduct

Name: Z-0167-04 CryoValve Pulmonary Valve & Conduct
Creator: Cryolife Inc
Published: 2003-11-04
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-11-04 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Pulmonary Valve & Conduct on 2003-11-04. The reason FDA records is "CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0167-04
Status: Terminated
Initiated: 2003-11-04
Posted: 2003-11-27
Terminated: 2004-05-06
Recalling firm: Artivion, Inc.
Product: CryoValve Pulmonary Valve & Conduct
Product code: MIE Heart-Valve, Allograft
Reason for recall: CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
FDA root cause: Other
Action: Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification.
Quantity in commerce: One unit
Distribution: The tissue was shipped to one hospital in MO.
Product codes and lots: Model Number PV00, Serial Number 8041312

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)