FDA Recalls FLIXENE Vascular Graft Devices for Component Separation
Atrium Medical Corporation recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.
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 is an FDA Class II recall of a high-risk implantable vascular device where component separation poses potential harm in clinical use. However, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3.
Plain-English summary
Atrium Medical Corporation is recalling the FLIXENE Double-Ended Slider GDS vascular graft devices due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the two pieces.
The separation of these components may impair the function of the vascular graft during clinical use. This defect was identified through complaints describing the physical separation.
The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units distributed internationally across numerous countries.
Patients and healthcare providers with these devices should contact their healthcare provider for guidance. Healthcare facilities should review their device inventory to identify any affected units.
The recalled product
- Product
- FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
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: 25129
- UDI-DI: 00650862251296.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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