FDA-Device2024-08-14Class II
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue 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 arteries, 1 patch
Manufactured in
1655 Roberts Blvd Nw, Kennesaw, GA, United States
Products
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2024Don't want to check this manually?
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