Z-0866-03

CryoValve Allograft, Heart valve

Name: Z-0866-03 CryoValve Allograft, Heart valve
Creator: Cryolife Inc
Published: 2003-04-30
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-04-30 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Allograft, Heart valve on 2003-04-30. The reason FDA records is "Microorganisms were detected in associated allografts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0866-03
Status: Terminated
Initiated: 2003-04-30
Posted: 2003-05-22
Terminated: 2004-04-29
Recalling firm: Artivion, Inc.
Product: CryoValve Allograft, Heart valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: Microorganisms were detected in associated allografts.
FDA root cause: Other
Action: Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.
Quantity in commerce: 8 units
Distribution: The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.
Product codes and lots: Donor #61838, Serial #7691913, Model #SGPV00; Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00; Donor #64779, Serial #7883080, Model #SGPV00; Donor #64779 77888910, Model #SGPV00; Donor #64779, Serial #7888909, Model #SGAV00; and Donor #63941, Serial #7894710, 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)