FLIXENE Vascular Graft Recall for Swivel Rod Component Separation
Atrium Medical is recalling FLIXENE vascular grafts due to complaints of separation between the Swivel Rod and Swivel Core components. The recall affects 53,308 units worldwide, including 11,236 in the US.
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 a Class II medical device recall of a vascular graft due to structural defect (component separation) that poses a risk of harm. No illnesses or injuries have been reported in the source material.
Plain-English summary
FLIXENE vascular grafts (Model 6X30, 1GDS, GW, Single-Ended Slider GDS) manufactured by Atrium Medical Corporation are being recalled. The recall was initiated due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core and the appearance of notable gaps between the two components.
The affected recall encompasses 53,308 units, with 11,236 distributed in the US and Puerto Rico, and 42,072 units distributed outside the US to numerous countries worldwide.
The recalled product
- Product
- FLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- structural-defect
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: 25125
- UDI-DI: 00650862251258.
Distribution
Distributed nationwide across the United States.
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