FLIXENE vascular graft recalled for slider separation defect
Atrium Medical recalls FLIXENE vascular grafts due to reported separation between the slider rod and swivel core. Affected grafts may fail to function properly if deployed.
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 risk-of-harm medical device recall involving a structural defect in a high-risk vascular graft with no reported illnesses or injuries documented in the source. The separation defect could compromise device deployment and function, meeting the rubric criterion for High severity.
Plain-English summary
FLIXENE single-ended slider GDS vascular grafts manufactured by Atrium Medical Corporation are being recalled due to complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap reported between the two components.
Vascular grafts are implantable medical devices used to restore or replace blood vessel function. If the slider rod separates from the swivel core, the graft may not deploy or function as intended, potentially compromising proper device operation.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally across numerous countries. Healthcare facilities and patients should contact Atrium Medical Corporation for guidance on affected devices and any appropriate clinical action.
The recalled product
- Product
- FLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- device-malfunction
- structural-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: 25126
- UDI-DI: 00650862251265.
Distribution
Distributed nationwide across the United States.
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