Z-0672-03

CryoValve Allograft, Heart valve

Name: Z-0672-03 CryoValve Allograft, Heart valve
Creator: Cryolife Inc
Published: 2003-02-04
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-02-04 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Allograft, Heart valve on 2003-02-04. The reason FDA records is "Microorganisms were detected in distributed allografts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0672-03
Status: Terminated
Initiated: 2003-02-04
Posted: 2003-03-21
Terminated: 2003-07-16
Recalling firm: Artivion, Inc.
Product: CryoValve Allograft, Heart valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: Microorganisms were detected in distributed allografts.
FDA root cause: Other
Action: CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.
Quantity in commerce: 2 units
Distribution: The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
Product codes and lots: Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.

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)