CryoValve SG Heart Valve (Artivion) – Bacterial Contamination (2024)
Blood culture contamination can compromise medical device safety.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Brand
Artivion, Inc
Lot Codes / Batch Numbers
Model/Catalog Number: SGPV00, Serial ID Number: 12578856, UDI-DI Number: 00877234000447, Expiration Date 04/05/2028
Products Sold
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Artivion, Inc is recalling CryoValve SG Cryopreserved Pulmonary Human Heart Valve due to The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026