FDAMay 28, 2024device
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
What to do
FDA enforcement status: Ongoing
Brands named
artivion
UPCs
00877234000447
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA(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 Prep...2024-05-28
- FDACryoValve SG Cryopreserved Pulmonary Human Heart Valve2024-03-06
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