Atrium Medical recalls FLIXENE vascular grafts (model 4-7X45, 2GDS) due to reported slider separation risks. Affected units may have a gap between swivel rod and core.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atr: Atrium Medical recalls FLIXENE vascular grafts (model 4-7X45, 2GDS) because users reported the slider swivel rod separating from the core, creating a gap. This could lead to complications during medical procedures if the graft fails.
The slider swivel rod can separate from the swivel core, creating a gap. This gap might cause the graft to malfunction during medical procedures, potentially leading to complications.
Patients using this vascular graft for medical procedures are most at risk. Healthcare providers who have this model in their inventory may also be affected.
Check for the product code 25138 or UDI-DI 00650862251388 on the FLIXENE vascular graft. The model is 4-7X45, 2GDS, and labeled as a Double-Ended Slider GDS.
Verify the product code 25138 or UDI-DI 00650862251388 on the FLIXENE vascular graft.
The recall reports complaints of slider separation, but the official notice does not state if this causes serious injury or death.
Check for product code 25138 or UDI-DI 00650862251388 on the FLIXENE vascular graft (model 4-7X45, 2GDS).
The recall does not specify a remedy, so contact Atrium Medical for guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2017-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2017-2024 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
