Z-1135-04

CryoValve, Conduit and Pulmonary Valve

Name: Z-1135-04 CryoValve, Conduit and Pulmonary Valve
Creator: Cryolife Inc
Published: 2004-07-01
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2004-07-01 / Terminated / root cause: sterility

FDA source

Cryolife Inc began a recall of CryoValve, Conduit and Pulmonary Valve on 2004-07-01. The reason FDA records is "The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired". 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-1135-04
Status: Terminated
Initiated: 2004-07-01
Posted: 2004-07-22
Terminated: 2004-09-03
Recalling firm: Artivion, Inc.
Product: CryoValve, Conduit and Pulmonary Valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired.
Root cause tag: sterility
FDA root cause: Other
Action: The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted.
Quantity in commerce: 1 unit
Distribution: CA, TX
Product codes and lots: Donor Number: 72560, Serial Number: 8178422, 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)