Z-0669-05

CryoValve, Pulmonary Valve and Conduit

Name: Z-0669-05 CryoValve, Pulmonary Valve and Conduit
Creator: Cryolife Inc
Published: 2005-01-12
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2005-01-12 / Terminated / root cause: sterility

FDA source

Cryolife Inc began a recall of CryoValve, Pulmonary Valve and Conduit on 2005-01-12. The reason FDA records is "During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0669-05
Status: Terminated
Initiated: 2005-01-12
Posted: 2005-04-06
Terminated: 2005-04-12
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Valve and Conduit
Product code: MIE Heart-Valve, Allograft
Reason for recall: During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.
Root cause tag: sterility
FDA root cause: Other
Action: Consignee was notified by letter on 01/12/2005.
Quantity in commerce: 1 tissue
Distribution: KS
Product codes and lots: Donor Number: 70022, Serial Number: 8056613, Model Number: PV00

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)