FDA-Device2024-08-14Class II
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Artivion, Inc
Hazard
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Sold states
US Nationwide distribution in the states of CA, DC, FL, and NY.
Affected count
2 valves
Manufactured in
1655 Roberts Blvd Nw, Kennesaw, GA, United States
Products
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2024Don't want to check this manually?
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