Vascular Graft Component Separation Risk Triggers Worldwide Device Recall
Atrium Medical recalls FLIXENE vascular grafts due to reported separation of the Swivel Rod from the Swivel Core, creating gaps that could affect device function. Over 53,000 units worldwide are affected.
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 medical device recall with reported device malfunction (component separation) but no adverse health events documented in the source text. Per the rubric, risk-of-harm products where injury has not been reported score at most 3.
Plain-English summary
Atrium Medical Corporation is recalling FLIXENE vascular grafts, a surgical implant used in blood vessel procedures. The recalled devices are model 6X30 with Single-Ended Slider GDS configuration.
The company received complaints reporting separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap developing between the two components. This mechanical failure could compromise device function during or after implantation.
The recall affects approximately 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, with the remainder distributed internationally across numerous countries.
Patients with these implanted devices and healthcare providers should contact Atrium Medical Corporation for guidance on whether device replacement or monitoring is necessary.
The recalled product
- Product
- FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- device-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: 25142
- UDI-DI: 00650862251425.
Distribution
Distributed nationwide across the United States.
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