CryoValve SG Pulmonary Heart Valve (Artivion) – Invalid Test Results (2024)
Invalid test results may be associated with tissue processing, but are unlikely to pose a direct health risk.
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 Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Brand
Artivion, Inc
Lot Codes / Batch Numbers
Serial #11673489, exp. 27Jan2026, and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Products Sold
Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Artivion, Inc is recalling CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft due to Grafts were found to have been approved, released, shipped and implanted with an invalid test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Recommended Action
Per FDA guidance
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.
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