Atrium Medical recalls FLIXENE vascular grafts (4-7X3: 2GDS, GWT-GW) due to reported separation of Slider GDS Swivel Rod from Swivel Core, creating a gap between pieces.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atrium Medical is recalling FLIXENE vascular grafts (model 4-7X30, 2GDS, GWT-GW) because users have reported the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap. This could lead to complications if the graft fails during medical use.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two pieces. This separation may cause the graft to fail during medical procedures, potentially leading to complications.
Patients using the FLIXENE vascular grafts (model 4-7X30, 2GDS, GWT-GW) are affected. Medical professionals who have implanted these grafts are most at risk.
Check for the product code 25141 or UDI-DI 00650862251418 on the FLIXENE vascular grafts. These are models 4-7X30, 2GDS, GWT-GW with a Double-Ended Slider GDS design.
Look for the product code 25141 or UDI-DI 00650862251418 on the FLIXENE vascular graft.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between the two pieces.
The official recall notice does not specify a remedy, so check with Atrium Medical for further instructions.
Check for the product code 25141 or UDI-DI 00650862251418 on the FLIXENE vascular grafts (model 4-7X30, 2GDS, GWT-GW).
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2018-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2018-2024 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.
