Atrium Medical recalls FLIXENE vascular grafts (model 4-7X35, 2GDS) due to reported slider separation. Affected users should contact for details.
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 (model 4-7X35, 2GDS) because users have reported the slider swivel rod separating from the swivel core, creating a gap between parts. This could lead to complications if the graft fails during use.
The hazard involves the slider swivel rod potentially separating from the swivel core, creating a gap. This separation could cause the graft to malfunction or fail during use, though the record does not specify serious injury cases.
Patients who have received the FLIXENE vascular graft (model 4-7X35, 2GDS) from Atrium Medical are most at risk. The recall applies to those with the specific product code.
Check for the product code 25129 on the FLIXENE vascular graft (model 4-7X35, 2GDS). The UDI-DI number 00650862251296 is also associated with this specific model.
Look for the product code 25129 or UDI-DI number 00650862251296 on the FLIXENE vascular graft.
The recall record does not specify the medical procedure or patient group affected.
Check for product code 25129 or UDI-DI number 00650862251296 on the graft.
The recall does not specify an immediate stop-use requirement; users should check product details first.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2013-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2013-2024 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.
