Atrium Medical recalls FLIXENE vascular grafts with reported slider swivel rod separation. Affected units have a gap between components; contact for remedy.
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 due to reported separation of the slider swivel rod from the swivel core, creating a gap between parts. This could lead to complications during medical procedures.
The slider swivel rod can separate from the swivel core, creating a gap between the two parts. This separation may cause complications during medical procedures if the graft is used.
Patients using FLIXENE vascular grafts for medical procedures are affected. Those with the specific product code (25142) and UDI-DI (00650862251425) are most at risk.
Check for the product code 25142 and UDI-DI 00650862251425 on the FLIXENE vascular graft. The product is sold as a single-ended slider GDS vascular graft.
Look for product code 25142 and UDI-DI 00650862251425 on the FLIXENE vascular graft.
Complaints of reported separation of the slider swivel rod from the swivel core and a notable gap between the two pieces.
Check for product code 25142 and UDI-DI 00650862251425. Contact Atrium Medical for further instructions.
The recall record does not specify a remedy.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2011-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2011-2024 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.