Atrium Medical recalls ADVANTA VXT vascular grafts due to reported slider separation risk. Affected models include 7X70, 1GDS, NH, STR-SW. No remedy specified in recall notice.
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 specific ADVANTA VXT vascular graft models because users reported the slider swivel rod separating from the swivel core, creating a gap between parts. This could lead to complications during medical procedures if the graft fails to stay properly connected.
The hazard involves the slider swivel rod potentially separating from the swivel core, creating a gap between the two components. This separation could compromise the graft's integrity during medical procedures, potentially causing complications if the connection fails.
Patients using the ADVANTA VXT vascular graft models with the specific product codes mentioned are most at risk. Healthcare providers who have these grafts in their inventory may also be affected.
Check for the product code 22027 on the ADVANTA VXT vascular graft. The specific model identifiers include 7X70, 1GDS, NH, and STR-SW. These products were sold with the UDI-DI: 00650862220278.
Review the product code and model identifiers to confirm if your vascular graft is affected.
The recall notice does not specify any remedy or fix for this issue.
The recall notice does not provide specific action steps for affected users.
Check for the product code 22027 and model identifiers 7X70, 1GDS, NH, STR-SW on the 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-1960-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1960-2024 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.