Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected models include 5X50, 1GDS, FH, STR-SW. Product code 22061. 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.
Atrium Medical is recalling specific ADVANTA VXT vascular graft models due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation could create a gap between the two parts, potentially causing 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 lead to complications during medical procedures if the graft is still in use.
Patients using the ADVANTA VXT vascular graft models with product code 220: 5X50, 1GDS, FH, STR-SW. Medical professionals who have implanted these grafts are most at risk.
Check for the product code 22061 on the ADVANTA VXT vascular graft. Affected models include 5X50, 1GDS, FH, STR-SW. The UDI-DI number 00650862220612 identifies the recalled items.
Look for product code 22061 on the vascular graft to confirm if it's affected.
The recall reports separation of the Slider GDS Swivel Rod from the Swivel Core, but the official notice does not specify if this causes serious injury or death.
Check for product code 22061 on the ADVANTA VXT vascular graft. Affected models include 5X50, 1GDS, FH, STR-SW with UDI-DI 00650862220612.
The recall does not specify a remedy, so contact Atrium Medical for further instructions.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1964-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1964-2024 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.