FDA Enforcement
Class II
Ongoing
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Recall: Z-2531-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2531-2024
- Event ID
- 94909
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Artivion, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 14, 2024
- Initiation Date
- May 28, 2024
- Classification Date
- August 8, 2024
- Address
- 1655 Roberts Blvd Nw, Kennesaw, GA, 30144-3632, United States
Description
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Reason
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Code Info
Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447
Distribution
US Nationwide distribution in the states of CA, DC, FL, and NY.
Quantity
2 valves