FDAAugust 25, 2021device
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
What to do
FDA enforcement status: Terminated
Brands named
atrium medicalatrium
UPCs
00650862220599
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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