FLIXENE Vascular Graft Recalled for Slider Swivel Rod Separation
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core. The separation could affect device function during vascular procedures.
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: This FDA Class II recall involves a documented structural defect (component separation) in a medical device used in vascular procedures. While the defect has been observed and reported, no injuries or illnesses have been reported, supporting a High rather than Severe classification.
Plain-English summary
FLIXENE vascular grafts (7X40, single-ended slider GDS model) manufactured by Atrium Medical Corporation are subject to this recall. Approximately 53,308 units have been identified, including 11,236 distributed in the United States and 42,072 distributed internationally.
The FDA classified this as a Class II recall due to reported separation of the slider GDS swivel rod from the swivel core, with a notable gap forming between the components. This structural defect could affect the device's function during vascular surgery procedures.
Affected units can be identified by product code 25062 and UDI-DI 00650862250626. Healthcare providers with these devices should evaluate their inventory and consult the FDA's guidance for appropriate management of affected units.
The recalled product
- Product
- FLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Hazard
- component-separation
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: 25062
- UDI-DI: 00650862250626.
Distribution
Distributed nationwide across the United States.
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