Z-2531-2024Class II

CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared...

Name: Z-2531-2024 CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared...
Creator: Artivion, Inc
Published: 2024-05-28
License: https://open.fda.gov/license/

Artivion, Inc. / initiated 2024-05-28 / Open, Classified

FDA source

Artivion, Inc began a recall of CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology on 2024-05-28. FDA classified it as Class II and gives the reason as "Grafts were found to have been approved, released, shipped and implanted with an invalid test results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2531-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-28
Posted: 2024-08-08
Recalling firm: Artivion, Inc.
Product: CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Product code: OHA Heart Valve, More Than Minimally Manipulated Allograft
Reason for recall: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
FDA root cause: Under Investigation by firm
Action: The recalling firm issued letters to their Field Representatives on 5/24/2024 or 5/28/2024 for distribution to the consignees via email or hand delivery. The first date consignees were notified was on 5/28/2024 by their Field Representative. The letter provided the details on the tissue the consignee received, the date it was implanted, and the implanting surgeon. The issue was described and it was pointed out there was no indication the impacted tissues were contaminated and unlikely to pose a health risk to the patient. The letter discussed the testing conducted on each allograft and that the identified allograft was reported to have an invalid Post-Processing Sterility test result or a Pre-Processing Culture test result (depending on the consignee letter), which represents a technical failure in the test, not an indication of a positive result. A response form was enclosed for return to acknowledge receipt of the notification.
Quantity in commerce: 2 valves
Distribution: US Nationwide distribution in the states of CA, DC, FL, and NY.
Product codes and lots: Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2531-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2531-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08
Z-2532-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-08

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)