Vascular graft component separation risk prompts medical device recall
Atrium Medical Corporation recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units are affected worldwide.
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 involving an implantable vascular graft with reported component separation. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' as component separation in a critical vascular device poses serious potential harm despite no documented injuries in the source text.
Plain-English summary
FLIXENE vascular grafts manufactured by Atrium Medical Corporation have been recalled due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall was initiated following complaints of separation between these two components, with reports of a notable gap between them.
Approximately 53,308 units are affected by this recall. Of these, 11,236 units were distributed in the United States and Puerto Rico, and 42,072 units were distributed worldwide to more than 70 countries. The FDA classified this as a Class II medical device recall.
The recalled product
- Product
- FLIXENE, 4-6X45, 2GDS, GWT. Double-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: 25134
- UDI-DI: 00650862251340.
Distribution
Distributed nationwide across the United States.
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