Vascular graft separation risk affects FLIXENE slider GDS devices
Atrium Medical recalls FLIXENE vascular grafts due to complaints of slider rod separation from the swivel core, which could affect device function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The device is a critical structural medical implant (vascular graft) where separation of core components poses a risk of serious harm. However, the source text does not report any illnesses, injuries, or hospitalizations. Per the severity rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Atrium Medical Corporation is recalling FLIXENE vascular grafts (6x50mm single-ended slider GDS model) following complaints of the slider GDS swivel rod separating from the swivel core, creating a notable gap between the two components.
This separation could compromise the structural integrity and function of the vascular graft. Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States (including Puerto Rico).
The affected devices were distributed to healthcare facilities across numerous countries. Healthcare providers and patients with implanted devices should contact their physician for clinical evaluation and guidance regarding their specific situation.
Atrium Medical Corporation is notifying healthcare facilities of this recall. Patients with implanted FLIXENE devices should consult their healthcare provider regarding assessment and any necessary follow-up care.
The recalled product
- Product
- FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
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: 25058
- UDI-DI: 00650862250589.
Distribution
Part of a larger recall action
This product is one of 68 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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