Z-0065-04

CryoValve, Pulmonary Heart Valve

Name: Z-0065-04 CryoValve, Pulmonary Heart Valve
Creator: Cryolife Inc
Published: 2003-09-25
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-09-25 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve, Pulmonary Heart Valve on 2003-09-25. The reason FDA records is "Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0065-04
Status: Terminated
Initiated: 2003-09-25
Posted: 2003-10-24
Terminated: 2004-05-06
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Heart Valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
FDA root cause: Other
Action: The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification.
Quantity in commerce: 1 unit
Distribution: The tissue was distributed to one physician in CA.
Product codes and lots: Donor #68830, Serial #8038836, Model #PV10

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)