FDA recall Z-2531-2024

Artivion, Inc · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-05-28
Report date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kennesaw, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2024