Z-0516-04

CryoValve, Pulmonary Valve & Conduit

Name: Z-0516-04 CryoValve, Pulmonary Valve & Conduit
Creator: Cryolife Inc
Published: 2003-11-10
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-11-10 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve, Pulmonary Valve & Conduit on 2003-11-10. The reason FDA records is "The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0516-04
Status: Terminated
Initiated: 2003-11-10
Posted: 2004-02-10
Terminated: 2004-05-06
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Valve & Conduit
Product code: MIE Heart-Valve, Allograft
Reason for recall: The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
FDA root cause: Other
Action: Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissue had been placed into quarantine.
Quantity in commerce: 1 unit
Distribution: The tissue was issued to one hospital in CA.
Product codes and lots: Donor number: 71237, Serial number: 8214013, 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)