Atrium Medical recalls FLIXENE vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific product codes; stop using if separation occurs.
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 is recalling FLIXENE vascular grafts (product code 25120) due to complaints about the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap between parts. This separation could lead to complications during medical procedures.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two parts. This separation could cause the graft to malfunction during medical procedures, potentially leading to complications.
Patients using the FLIXENE vascular grafts for medical procedures are most at risk. Healthcare providers who have the product in their inventory may also be affected.
Check for product code 25120 on the FLIXENE vascular graft. The UDI-DI number 00650862251203 is also associated with this specific model.
Inspect the Slider GDS Swivel Rod for separation from the Swivel Core and a gap between the two parts.
The product code is 25120.
Check for product code 25120 or UDI-DI number 00650862251203.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2006-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2006-2024 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.