Z-0841-2007

CryoValve, Pulmonary Valve & Conduit

Name: Z-0841-2007 CryoValve, Pulmonary Valve & Conduit
Creator: CryoLife, Inc.
Published: 2007-04-17
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2007-04-17 / Terminated

FDA source

CryoLife, Inc. began a recall of CryoValve, Pulmonary Valve & Conduit on 2007-04-17. The reason FDA records is "Donor tissue was released prior to information received regarding a pericardial effusion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0841-2007
Status: Terminated
Initiated: 2007-04-17
Posted: 2007-06-07
Terminated: 2007-12-31
Recalling firm: Artivion, Inc.
Product: CryoValve, Pulmonary Valve & Conduit
Product code: MIE Heart-Valve, Allograft
Reason for recall: Donor tissue was released prior to information received regarding a pericardial effusion.
FDA root cause: Other
Action: Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife
Quantity in commerce: 1 tissue
Distribution: AZ, CO
Product codes and lots: Donor number 87980, Serial number 8897314, Model Number 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)