Atrium Medical recalls FLIXENE vascular grafts with reported slider swivel rod separation. Affected units have a gap between components. Contact for remedy 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 is recalling FLIXENE vascular grafts due to reported separation of the slider swivel rod from the swivel core, creating a gap between components. This could lead to complications during medical procedures.
The slider swivel rod can separate from the swivel core, creating a gap between the two parts. This separation may cause complications during medical procedures if the graft is used.
Patients using the FLIXENE vascular grafts for medical procedures are affected. Those with the specific product code (25061) or UDI-DI (00650862250619) are most at risk.
Check for the product code 25061 or UDI-DI 00650862250619 on the FLIXENE vascular graft. The product is a single-ended slider GDS vascular graft.
Verify the product code (25061) or UDI-DI (00650862250619) on the FLIXENE vascular graft.
The recall indicates reported separation issues, so it's not recommended for use until the remedy is applied.
The recall record does not specify a remedy, so contact Atrium Medical for guidance.
Check for product code 25061 or UDI-DI 00650862250619 on the FLIXENE vascular graft.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2004-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2004-2024 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.
