Z-1187-03

Heart-valve, allograft

Name: Z-1187-03 Heart-valve, allograft
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 Heart-valve, allograft on 2003-02-04. The reason FDA records is "Donor of aortic valve had procurement cultures that were positive for E-coli". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1187-03
Status: Terminated
Initiated: 2003-02-04
Posted: 2003-08-28
Terminated: 2003-08-28
Recalling firm: Artivion, Inc.
Product: Heart-valve, allograft
Product code: MIE Heart-Valve, Allograft
Reason for recall: Donor of aortic valve had procurement cultures that were positive for E-coli.
FDA root cause: Other
Action: A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.
Quantity in commerce: 1 unit
Distribution: Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
Product codes and lots: Donor #60741, Model #SGAV10, Serial #783013

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)