Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes and product identifiers.
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 reports of the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap between the two parts. This separation could 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 the graft to malfunction during medical procedures, potentially leading to complications.
Patients using the recalled vascular grafts for medical procedures are affected. Medical professionals who have installed these grafts are most at risk due to potential complications during surgery.
Check for the product code 22221 and UDI-DI 00650862222210 on the vascular graft. The affected models include ADVANTA VXT, 7X70, 1GDS, FH, STR-TW.
Look for the product code 22221 and UDI-DI 00650862222210 on the vascular graft.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the two pieces.
Check for the product code 22221 and UDI-DI 00650862222210 on the vascular graft. If you have the affected model, contact Atrium Medical for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1987-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1987-2024 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.