Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation risk. Affected models include 6X40, 1GDS, NH, STR-TW. Product code 22169.
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 G: GDS Swivel Rod from the Swivel Core. This separation could create a notable 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 the specific product codes mentioned are affected. Medical professionals who have implanted these grafts are at the highest risk.
Check for the product code 22169 on the device. The affected models include ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. The UDI-DI number 00650862221695 is also associated with this recall.
Look for product code 22169 on the device to confirm if it is affected.
The recall reports separation of the Slider GDS Swivel Rod from the Swivel Core, but no specific injuries or deaths have been reported. The risk is considered low based on the complaints.
Check the product code on the device. If it matches 22169, contact Atrium Medical for further instructions.
Affected devices have product code 22169 and include the model ADVANTA VXT, 6X40, 1GDS, NH, STR-TW. The UDI-DI number 00650862221695 is also associated with this recall.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1973-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1973-2024 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.