Z-0673-03

CryoValve Allograft, heart valve

Name: Z-0673-03 CryoValve Allograft, heart valve
Creator: Cryolife Inc
Published: 2003-02-18
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-02-18 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Allograft, heart valve on 2003-02-18. The reason FDA records is "Microorganisms were detected in distributed donor tissue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0673-03
Status: Terminated
Initiated: 2003-02-18
Posted: 2003-03-21
Terminated: 2003-07-21
Recalling firm: Artivion, Inc.
Product: CryoValve Allograft, heart valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: Microorganisms were detected in distributed donor tissue.
FDA root cause: Other
Action: Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached to affirm receipt of the notification.
Quantity in commerce: There were six (6) individual heart valve allografts.
Distribution: Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts.
Product codes and lots: Donor #61266, Serial # 7701969, Model #AV00; Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, 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)