Vascular graft device recalled due to swivel rod separation
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect 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: This is an FDA Class II medical device recall involving reported separation of a critical component in a vascular graft. The source text does not report any illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Atrium Medical Corporation is recalling FLIXENE 4-7X45 vascular grafts (product code 25138) featuring a Double-Ended Slider GDS design. The recall affects 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units in other countries.
The company has received complaints indicating separation of the Slider GDS Swivel Rod from the Swivel Core, with reports of a notable gap between the two components. This separation could compromise the device's structural integrity and function.
Patients who have received FLIXENE vascular grafts as part of their vascular repair or replacement procedures are potentially affected by this recall. Healthcare providers and patients should be aware of the reported device defect.
The recalled product
- Product
- FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-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: 25138
- UDI-DI: 00650862251388.
Distribution
Distributed nationwide across the United States.
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