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Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vasc
Recalled October 6, 2021 · FDA recall Z-2589-2021 · Atrium Medical
Hazard
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling. · FDA Class II
Units
28 units
Sold at
Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
Description
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Product
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.
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →