Artivion, Inc FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. Matched by name to AORT.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Class IIMay 28, 2024Grafts were found to have been approved, released, shipped a	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.	Class IIDevices	May 28, 2024
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerClass IIMay 28, 2024Grafts were found to have been approved, released, shipped a	Grafts were found to have been approved, released, shipped and implanted with an invalid test results.	Class IIDevices	May 28, 2024
CryoValve SG Cryopreserved Pulmonary Human Heart ValveClass IIMar 6, 2024The blood cultures performed as part of the organ donation p	The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.	Class IIDevices	Mar 6, 2024