CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allogr...
FDA Recall #Z-2531-2024 — Class II — May 28, 2024
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.
Recalling Firm
Artivion, Inc — Kennesaw, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 valves
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated