FLIXENE Vascular Graft Recall Due to Swivel Rod Component Separation
Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise 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: Scores as High (3) because it is a Class II risk-of-harm medical device (vascular graft component separation could cause serious harm) but no illnesses or injuries have been reported.
Plain-English summary
This is a recall of the FLIXENE, 7X50, 1GDS, GW vascular graft, a single-ended slider GDS device manufactured by Atrium Medical Corporation. The FDA has classified this as a Class II recall.
The recall addresses complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap reported between the two pieces. In an implanted vascular graft, component separation could affect device function.
A total of 53,308 units have been recalled, including 11,236 units distributed in the United States and Puerto Rico, and 42,072 units distributed internationally to numerous countries worldwide.
Patients with implanted FLIXENE grafts should contact their physician to discuss any concerns about their device. Healthcare providers should review this recall notice and consider appropriate follow-up for patients with affected devices.
The recalled product
- Product
- FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Hazard
- component-separation
- mechanical-failure
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: 25059
- UDI-DI: 00650862250596.
Distribution
Distributed nationwide across the United States.
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