Device product
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Z-2531-2024
Product summary
- Firm
- Artivion, Inc
- Event
- Event 94909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 valves
- Official record key
device-enforcement:Z-2531-2024
Official wording
Reason: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Code information: Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Distribution pattern: US Nationwide distribution in the states of CA, DC, FL, and NY.
Derived failure modes
-
Unknown
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.