Z-0548-04

CryoValve Pulmonary Valve and Conduit

Name: Z-0548-04 CryoValve Pulmonary Valve and Conduit
Creator: Cryolife Inc
Published: 2003-12-10
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2003-12-10 / Terminated

FDA source

Cryolife Inc began a recall of CryoValve Pulmonary Valve and Conduit on 2003-12-10. The reason FDA records is "As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0548-04
Status: Terminated
Initiated: 2003-12-10
Posted: 2004-02-25
Terminated: 2004-07-23
Recalling firm: Artivion, Inc.
Product: CryoValve Pulmonary Valve and Conduit
Product code: MIE Heart-Valve, Allograft
Reason for recall: As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
FDA root cause: Other
Action: The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997.
Quantity in commerce: 1 unit
Distribution: The allograft was shipped to one physician in TX.
Product codes and lots: Donor #29640, Serial #6194362, Model #PV00 (Pulmonary Valve)

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)