Atrium Medical recalls FLIXENE vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have a gap between components. 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:ium Medical is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components. 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 could compromise the graft's function during medical procedures, potentially causing complications if the graft fails.
Patients using the FLIXENE vascular grafts with the specific model code (7X40, 1GDS, GW) are affected. Medical professionals who have implanted these grafts are at highest risk.
Check for the product code 25062 and UDI-DI 00650862250626 on the FLIXENE vascular graft. The specific model is 7X40, 1GDS, GW. Single-Ended Slider GDS Vascular grafts are affected.
Look for product code 25062 and UDI-DI 00650862250626 on the FLIXENE vascular graft.
The recall reports separation of the Slider GDS Swivel Rod from the Swivel Core, but the official notice does not specify if this causes serious injury or death.
Check for product code 25062 and UDI-DI 00650862250626 on the graft. Affected units are the 7X40, 1GDS, GW model.
The recall does not specify any remedy or action steps for affected users.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2005-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2005-2024 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.
