FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results
Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.
- Product
- (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 Tis
- Category
- Medical Device
- Distribution
- Distributed nationwide