Vascular Graft Swivel Component Separation Recall Affects Thousands Nationwide
FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with reported component separation in an implanted vascular graft. No illnesses or injuries reported, but the mechanical defect poses a risk given the critical nature of vascular grafts.
Plain-English summary
Atrium Medical Corporation is recalling FLIXENE vascular grafts (model 4-6X35, 2GDS, GWT-GW). These are double-ended slider grafts with swivel technology used in vascular applications. The company received complaints that the swivel rod separates from the swivel core, with patients and providers reporting a notable gap between the two pieces.
The recall affects 53,308 units worldwide. In the United States, 11,236 units were distributed (including Puerto Rico). An additional 42,072 units were distributed internationally across 60 countries.
The FDA classified this as a Class II medical device recall (Z-2012-2024).
The recalled product
- Product
- FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular grafts
- Hazard
- component-separation
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: 25128
- UDI-DI: 00650862251289.
Distribution
Distributed nationwide across the United States.
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