Atrium Medical recalls FLIXENE vascular grafts (product code 25134) due to reported separation of the slider swivel rod from the swivel core, creating a gap between components.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atr:ium Medical is recalling FLIXENE vascular grafts (model 4-6X45, 2GDS, GWT) because users have reported the slider swivel rod separating from the swivel core, creating a gap. This separation could potentially lead to complications during medical procedures.
The slider swivel rod can separate from the swivel core, creating a gap between the two components. 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 model (4-6X45, 2GDS, GWT) are most at risk.
Check for the product code 25134 on the FLIXENE vascular graft (model 4-6X45, 2GDS, GWT). The UDI-DI number 00650862251340 is also associated with this product.
Verify the product code 25134 and UDI-DI number 00650862251340 on the FLIXENE vascular graft.
The recall is based on reported separations of the slider swivel rod from the swivel core, but no specific injuries or deaths have been reported. The hazard is described as low risk.
The recall does not specify a remedy, so check the product details to confirm if it's affected and contact Atrium Medical for further guidance.
Look for the product code 25134 and UDI-DI number 00650862251340 on the graft. This specific model (4-6X45, 2GDS, GWT) is affected.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2014-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2014-2024 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.
