Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FLIXENE Recalled by Atrium Medical Corporation Due to Complaints of reported separation of the Slider GDS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.
Affected Products
FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
Quantity: 53,308 units (US: 11, 236; OUS: 42,072)
Why Was This Recalled?
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Atrium Medical Corporation
Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report