Class II

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

Artivion, Inc · May 28, 2024

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

2 valves

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2531-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.