Brand
Artivion, Inc
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Artivion, Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-08-14FDA-DeviceClass 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.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- 2024-08-14FDA-DeviceClass IICryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- 2024-04-24FDA-DeviceClass IICryoValve SG Cryopreserved Pulmonary Human Heart Valve
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
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