(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.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
US Nationwide distribution in the states of CA, DC, FL, and NY.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2532-2024