Atrium Medical recalls ADVANTA VXT vascular grafts 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 specific ADVANTA VXT vascular graft models because users have reported the Slider GDS Swivel Rod separating from the Sw. Core, creating a gap. This could potentially lead to complications during medical procedures if the graft fails to stay properly connected.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two parts. This gap may cause the graft to malfunction during medical procedures, potentially leading to complications if the connection fails.
Patients using the ADVANTA VXT vascular graft models with the specific product codes mentioned are affected. Medical professionals who have implanted these grafts are at higher risk of complications if the separation occurs.
Check for the product code 22016 and UDI-DI 00650862220162 on the vascular graft. The affected models include ADVANTA VXT, 5X50, 1GDS, NH, STR-SW.
Look for the product code 22016 and UDI-DI 00650862220162 on the vascular graft to confirm if it is affected.
Check if your vascular graft has the product code 22016 and UDI-DI 00650862220162 to determine if it is affected.
The recall does not specify a remedy, so contact Atrium Medical directly for guidance.
Affected grafts have the product code 22016 and UDI-DI 00650862220162. Check the label on the 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-1954-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1954-2024 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.
