Z-1545-2024Class II

CryoValve SG Cryopreserved Pulmonary Human Heart Valve

Name: Z-1545-2024 CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Creator: Artivion, Inc
Published: 2024-03-06
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2024-03-06 / Open, Classified

FDA source

Artivion, Inc began a recall of CryoValve SG Cryopreserved Pulmonary Human Heart Valve on 2024-03-06. FDA classified it as Class II and gives the reason as "The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1545-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-06
Posted: 2024-04-16
Recalling firm: Artivion, Inc.
Product: CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Product code: OHA Heart Valve, More Than Minimally Manipulated Allograft
Reason for recall: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
FDA root cause: Under Investigation by firm
Action: The single consignee was notified via email on 03/06/2024 with an amended letter sent on 03/14/2024. The first letter indicated to quarantine and return the affected unit, if not implanted. The consignee was requested to complete and return the response form.
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of Ohio.
Product codes and lots: Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1545-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-16

Product code OHA

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)