Atrium Medical recalls FLIXENE vascular grafts (model 4-7X45, 2GDS) due to reported separation of the slider swivel rod from the 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: Atrium Medical is recalling FLIXENE vascular grafts (model 4-7X45, 2GDS) because users have reported the slider swivel rod separating from the swivel core, creating a gap between the two 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 components. This separation could potentially cause complications during medical procedures if the gap leads to improper function or movement of the graft.
Patients who have received FLIXENE vascular grafts (model 4-7X45, 2GDS) from Atrium Medical are affected. Medical professionals using these grafts during procedures may also be at risk.
Check for FLIXENE vascular grafts with model number 4-7X45 and 2GDS. The product code is 25135, and the UDI-DI is 00650862251357.
Verify the model number (4-7X45, 2GDS) and product code (25135) on the vascular graft.
No, this recall specifically applies to FLIXENE vascular grafts with model number 4-7X45 and 2GDS.
The recall record does not specify a remedy, so contact Atrium Medical for further instructions.
Check the product code (25135) and UDI-DI (00650862251357) on the graft to confirm it is part of this recall.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2015-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2015-2024 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.
