Atrium Medical recalls FLIXENE vascular grafts (model 4-6X35, 2GDS, GWT-GW) 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 recalls FLIXENE vascular grafts (model 4-6X35, 2GDS, GWT-GW) because users reported separation of the slider swivel rod from the swivel core. 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 between the two parts. This separation could compromise the graft's function and lead to complications if it occurs during medical use.
Patients using the FLIXENE vascular grafts (model 4-6X35, 2GDS, GWT-GW) are most at risk. Healthcare providers who have this model in their inventory may also be affected.
Check for the product code 25128 and UDI-DI 00650862251289 on the FLIXENE vascular graft. The model is 4-6X35, 2GDS, GWT-GW.
Reach out to Atrium Medical Corporation for specific recall instructions and product details.
The recall reports complaints of slider separation, but the official notice does not specify if this causes serious injury or death.
Check for product code 25128 and UDI-DI 00650862251289 on the FLIXENE vascular graft model 4-6X35, 2GDS, GWT-GW.
The recall does not specify a remedy, so contact Atrium Medical Corporation for instructions.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2012-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2012-2024 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.
