Atrium Medical recalls FLIXENE vascular grafts (product code 25058) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.
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 (product code : 25058) because users have reported the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap between the two parts. This separation could potentially lead to complications during medical procedures.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two components. This separation may cause complications during medical procedures if the graft is used without proper alignment.
Patients who have received FLIXENE vascular grafts (product code 25058) from Atrium Medical are most at risk. Healthcare providers using these grafts for medical procedures may also be affected.
Check for the product code 25058 on the FLIXENE vascular graft packaging or documentation. The product is identified by the UDI-DI: 00650862250589.
Verify the product code on the packaging or documentation to confirm if it matches 25058.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components. However, the hazard is described as a potential complication during medical procedures, not an immediate risk of serious injury.
Check for the product code 25058 on the packaging or documentation. The product is identified by the UDI-DI: 00650862250589.
The recall does not specify a remedy, so there are no immediate actions required. Contact Atrium Medical for further guidance if you have the product.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2002-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2002-2024 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.
