Medical Device Recall: (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 Pulmon
Artivion, Inc · May 28, 2024
Reason for Recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Product Description
(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.
Distribution
US Nationwide distribution in the states of CA, DC, FL, and NY.
States Affected
NATIONWIDE
Quantity Affected
2 arteries, 1 patch
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2532-2024
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.