FLIXENE Vascular Graft Recalled for Slider Component Separation
Atrium Medical is recalling the FLIXENE vascular graft due to reported separation of the Slider GDS Swivel Rod from its core. Component separation could affect graft 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 for a vascular graft with reported component separation. While the hazard presents a risk of device malfunction in a high-risk medical application, the source text does not report any hospitalizations or patient injuries. The recall qualifies as 'High' per the rubric: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling the FLIXENE 4-6X45 2GDS GWT-GW Double-Ended Slider GDS vascular graft. The company has received complaints reporting that the Slider GDS Swivel Rod separates from the Swivel Core, leaving a notable gap between the two components. This separation could affect the graft's function and safety.
The recall affects 53,308 units distributed worldwide, with 11,236 units in the United States and its territories and 42,072 units in international markets. Patients who may have received this device should consult with their healthcare provider about their individual risk.
The recalled product
- Product
- FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- 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: 25137
- UDI-DI: 00650862251371.
Distribution
Distributed nationwide across the United States.
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