FLIXENE Vascular Graft Slider Rod Separation Defect Recall
Atrium Medical Corporation has recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the pieces.
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 vascular graft with reported mechanical component separation. As a risk-of-harm product with no injuries yet reported in the source text, it meets the High (3) severity criterion.
Plain-English summary
The FLIXENE vascular graft (model 4-7X45, 2GDS, GWT, Double-Ended Slider GDS) manufactured by Atrium Medical Corporation is being recalled by the FDA. The recall was prompted by complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with reports of a notable gap between the two components.
Approximately 53,308 units of this vascular graft have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units distributed internationally.
The FDA has classified this as a Class II recall. Patients with this device implanted should consult with their healthcare provider. Healthcare providers with affected products should reference the FDA recall notice for guidance.
The recalled product
- Product
- FLIXENE, 4-7X45, 2GDS, GWT. 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: 25135
- UDI-DI: 00650862251357.
Distribution
Distributed nationwide across the United States.
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