Atrium Medical recalls FLIXENE vascular grafts with reported slider swivel rod separation. Affected units have a gap between slider and core components. Consumers 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.
Atrium Medical is recalling FLIXENE vascular grafts due to reports of the slider swivel rod separating from the swivel core, creating a gap between the two parts. This could lead to complications during medical procedures if the graft fails.
The slider swivel rod can separate from the swivel core, creating a gap between the two components. This separation could potentially cause the graft to malfunction during medical procedures.
Patients who received FLIXENE vascular grafts with the specific product code 25126 are affected. Medical professionals using these grafts during procedures may also be at risk.
Check for the product code 25126 on the FLIXENE vascular graft packaging or label. The UDI-DI code 00650862251265 is also associated with this specific model.
Reach out to Atrium Medical Corporation for specific guidance on affected units and next steps.
The recall reports separation of the slider swivel rod from the swivel core, but no specific injuries or deaths have been reported. The risk is low based on the complaints.
Check for the product code 25126 or UDI-DI code 00650862251265 on the graft packaging or label.
Contact Atrium Medical Corporation for details about affected units and next steps.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2008-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2008-2024 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.