Atrium Medical recalls FLIXENE vascular grafts with reported slider swivel rod separation. Affected models include 7X50, 1GDS, STR. Check product code 25056 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 is recalling FLIXENE vascular grafts due to 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.
The slider swivel rod can separate from the swivel core, creating a gap. This separation may cause the graft to malfunction during medical procedures, potentially leading to complications.
Patients using this vascular graft during surgery or medical procedures are most at risk. The recall applies to specific model numbers sold by Atrium Medical.
Check for product code 25056 on the FLIXENE vascular graft. The model includes 7X50, 1GDS, STR. Single-Ended Slider GDS.
Look for product code 25056 on the FLIXENE vascular graft.
The recall reports separation of the slider swivel rod from the swivel core, but the official notice does not specify if this causes serious injury or death.
The recall does not provide a remedy, so no action is required beyond checking the product code.
Check for product code 25056 on the FLIXENE vascular graft, which includes model numbers 7X50, 1GDS, STR.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2010-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2010-2024 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.
