Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific product codes; contact for remedy.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atr:ium Medical is recalling certain ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation could create a gap between the two pieces, potentially causing complications during medical procedures.
The Slider GDS Swivel Rod may separate from the Swivel Core, creating a gap between the two components. This separation could lead to complications during medical procedures if the gap affects the graft's function.
Patients using the recalled vascular grafts for medical procedures are most at risk. The affected units are specific models sold with product codes starting with 22213.
Check for product code 22213 on the vascular graft. The affected models include ADVANTA VXT, 7X50, 1GDS, FH, STR-TW. These were sold with the UDI-DI: 00650862222135.
Look for product code 22213 on the vascular graft to confirm if it is affected.
The recall is for reported separation of the Slider GDS Swivel Rod from the Swivel Core, but no injuries have been reported. The hazard is low risk as it does not cause immediate harm in normal use.
Check for product code 22213 on the vascular graft. Affected models include ADVANTA VXT, 7X50, 1GDS, FH, STR-TW with UDI-DI: 00650862222135.
The recall does not specify a remedy, so contact Atrium Medical directly for guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1984-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1984-2024 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.
