Z-1560-2011

Pulmonary Valve & Conduit SG Used in heart surgery

Name: Z-1560-2011 Pulmonary Valve & Conduit SG Used in heart surgery
Creator: CryoLife, Inc.
Published: 2011-02-17
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2011-02-17 / Terminated

FDA source

CryoLife, Inc. began a recall of Pulmonary Valve & Conduit SG Used in heart surgery on 2011-02-17. The reason FDA records is "Staphylococcus aureus (not methicillin resistant) identified in companion tissue". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1560-2011
Status: Terminated
Initiated: 2011-02-17
Posted: 2011-03-04
Terminated: 2012-04-24
Recalling firm: Artivion, Inc.
Product: Pulmonary Valve & Conduit SG Used in heart surgery
Product code: DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Reason for recall: Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
FDA root cause: Other
Action: CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.
Quantity in commerce: One
Distribution: Nationwide Distribution including AZ & NV
Product codes and lots: Serial No. 9560908 - Model SGPV00

Product code DXZ

K092021UnclassifiedCryovalve Sg Pulmonary Human Heart Valve (and Conduit)Cryolife, Inc. / cleared 2010-05-25

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)