Artivion, Inc recalls CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner

Recalled August 14, 2024 · FDA recall Z-2531-2024 · Artivion

Hazard

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

Units

2 valves

Sold at

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

Description

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

Product

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

Manufacturer(s)

Artivion, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →