Z-1188-03

CryoValve Heart Valve

Name: Z-1188-03 CryoValve Heart Valve
Creator: Cryolife Inc
Published: 2003-04-01
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-04-01 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Heart Valve on 2003-04-01. The reason FDA records is "CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1188-03
Status: Terminated
Initiated: 2003-04-01
Posted: 2003-08-29
Terminated: 2004-10-21
Recalling firm: Artivion, Inc.
Product: CryoValve Heart Valve
Product code: MIE Heart-Valve, Allograft
Reason for recall: CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors.
FDA root cause: Other
Action: Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife.
Quantity in commerce: 325 units
Distribution: Tissues were distributed to hospitals and physicians located nationwide and worldwide.
Product codes and lots: Donors processed prior to 1/26/1998

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)