Vascular Graft Device Recalled for Slider Rod Separation Risk
Atrium Medical Corporation is recalling approximately 53,308 FLIXENE vascular graft units worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating gaps that could affect device performance.
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 recall of a high-risk implantable medical device with confirmed structural defects (component separation). The hazard poses significant risk of device malfunction, though no injuries or hospitalizations have been reported in the source text.
Plain-English summary
Atrium Medical Corporation is recalling approximately 53,308 units of the FLIXENE vascular graft device (Product Code 25056) worldwide. The recall was initiated due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with notable gaps observed between the two components.
This structural separation could compromise the device's integrity and function during clinical use. The affected devices have been distributed throughout the United States, Puerto Rico, and to numerous countries internationally.
Patients with this device implanted should contact their healthcare provider to discuss the situation. Healthcare providers and facilities should identify affected units using Product Code 25056 (UDI-DI: 00650862250565) and contact Atrium Medical Corporation for further guidance.
The recalled product
- Product
- FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- device-malfunction
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: 25056
- UDI-DI: 00650862250565.
Distribution
Distributed nationwide across the United States.
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