Home / Recalls / Artivion, Inc / Z-2531-2024

Z-2531-2024 Class II Ongoing

Recalled by Artivion, Inc — Kennesaw, GA

Recall Details

Product Type: Devices
Report Date: August 14, 2024
Initiation Date: May 28, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 valves

Product Description

CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.

Reason for Recall

Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

Distribution Pattern

US Nationwide distribution in the states of CA, DC, FL, and NY.

Code Information

Serial #11673489, exp. 27Jan2026; and serial #12657716, exp. 15Aug2028, UDI-DI: 00877234000447