Vascular graft recalled for separation of slider mechanism
Atrium Medical Corporation recalls FLIXENE vascular grafts due to separation of the slider swivel rod from the core assembly. The device defect affects 53,308 units distributed 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: FDA Class II medical device recall of a vascular graft. The reported separation of the slider mechanism represents a risk-of-harm defect affecting device integrity.
Plain-English summary
Atrium Medical Corporation has recalled the FLIXENE vascular graft, model 6X40, 1GDS, GW (Single-Ended Slider GDS), due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap between the two pieces. The FDA has classified this as a Class II recall.
The recalled units were distributed worldwide, including throughout the United States (including Puerto Rico) and to numerous countries. A total of 53,308 units were affected, including 11,236 units distributed in the United States and 42,072 units distributed outside the United States.
Patients who have received this device or healthcare providers managing patients with this device should contact Atrium Medical Corporation or their healthcare provider regarding the recall and appropriate next steps.
The recalled product
- Product
- FLIXENE, 6X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- assembly-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: 25061
- UDI-DI: 00650862250619.
Distribution
Distributed nationwide across the United States.
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