Z-0719-03

CryoValve Allograft, Heart valve

Name: Z-0719-03 CryoValve Allograft, Heart valve
Creator: Cryolife Inc
Published: 2003-02-24
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-02-24 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Allograft, Heart valve on 2003-02-24. The reason FDA records is "Pre-processing cultures detected certain microorganisms in donor tissue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0719-03
Status: Terminated
Initiated: 2003-02-24
Posted: 2003-04-10
Terminated: 2004-07-23
Recalling firm: Artivion, Inc.
Product: CryoValve Allograft, Heart valve.
Product code: MIE Heart-Valve, Allograft
Reason for recall: Pre-processing cultures detected certain microorganisms in donor tissue.
FDA root cause: Other
Action: Consignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue.
Quantity in commerce: 2 individual heart valve allografts.
Distribution: Heart allografts were distributed to two hospitals in OH and Quebec, Canada.
Product codes and lots: Aortic Valve & Conduit, Donor #29976, Serial #6212891, Model #AV00 and Pulmonary Valve & Conduit Donor #51562, Serial #7093095, Model #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)