Artivion Recalls
3 recalls on record · April 24, 2024 to August 14, 2024 · Medical Devices
August 14, 2024Medical DevicesFDA
Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue
Hazard: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
August 14, 2024Medical DevicesFDA
Artivion, Inc recalls CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner
Hazard: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
April 24, 2024Medical DevicesFDA
Artivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Hazard: The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.