Atrium Medical recalls FLIXENE vascular grafts (model 4-6X45, 2GDS, GWT-GW) due to reported slider separation risks. Affected units may have a gap between swivel rod and core.
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 4-6X45, 2GDS, GWT-GW) because users reported separation of the slider swivel rod from the swivel core, creating a gap between the two parts. This could lead to complications during medical procedures if the graft fails to stay properly connected.
The hazard involves the slider swivel rod potentially separating from the swivel core, creating a gap. This could cause the graft to malfunction during medical procedures if the connection fails.
Patients using this vascular graft during medical procedures are most at risk. The recall applies to specific models sold under the FLIXENE brand.
Check for the product code 25137 or UDI-DI 00650862251371 on the FLIXENE vascular graft. The model is 4-6X45, 2GDS, GWT-GW.
Look for the product code 25137 or UDI-DI 00650862251371 on the FLIXENE vascular graft.
The recall reports separation issues but does not state that the product causes serious injury or death in normal use. The hazard is described as a potential gap between parts.
Check for the product code 25137 or UDI-DI 00650862251371 on the FLIXENE vascular graft model 4-6X45, 2GDS, GWT-GW.
The recall does not provide a remedy, so no action is required beyond checking if you have the specific model.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2016-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2016-2024 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.
