Z-1219-2011

Pulmonary Valve & Conduit SG Used in heart surgery

Name: Z-1219-2011 Pulmonary Valve & Conduit SG Used in heart surgery
Creator: CryoLife, Inc.
Published: 2011-01-07
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2011-01-07 / Terminated

FDA source

CryoLife, Inc. began a recall of Pulmonary Valve & Conduit SG Used in heart surgery on 2011-01-07. The reason FDA records is "A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1219-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2011-02-11
Terminated: 2011-11-01
Recalling firm: Artivion, Inc.
Product: Pulmonary Valve & Conduit SG Used in heart surgery
Product code: MIE Heart-Valve, Allograft
Reason for recall: A pre-processing culture performed on a companion allograft (Aortic Valve & Conduct SG) tested positive for Staphylococcus aureus.
FDA root cause: Other
Action: The firm, Cryolife, sent an "Urgent-Human Tissue Recall" letter dated January 7, 2011 to the consignee/customer. The letter describe the product, problem and action to be taken by the customer. The customer was instructed to determine if any additional patient surveillance or intervention was necessary, and to complete and return the enclosed postcard affirming that the notification was received. If you have any questions, please contact Cryolife's Medical Director at 1-678-290-4403.
Quantity in commerce: One
Distribution: Nationwide distribution: USA state of: MI
Product codes and lots: Serial Number 9748180

Product code MIE

K083106UnclassifiedCryovalve Sg Pulmonary Valve and ConduitCryolife, Inc. / cleared 2009-02-06

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)