Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected models include 6X80, 1GDS, NH, STR-TW. Stop using if separation occurs.
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 creates a notable gap between the two parts, which could lead to complications if the graft is used.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two parts. This separation may cause the graft to malfunction or become unstable during use, potentially leading to complications.
Patients who have received the ADVANTA VXT vascular graft models with the specific product codes listed. Those with the reported separation issue are at higher risk.
Check for the product code 22190 on the packaging or label. The affected models include ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. The UDI-DI code 00650862221909 is also associated with this recall.
Look for a gap between the Slider GDS Swivel Rod and Swivel Core. If separation occurs, stop using the graft immediately.
The recall is for reported separation of the Slider GDS Swivel Rod from the Swivel Core, which creates a gap. While this could lead to complications, the hazard is not described as causing serious injury in normal use.
Check for the product code 22190 on the packaging or label. Affected models include ADVANTA VXT, 6X80, 1GDS, NH, STR-TW with UDI-DI code 00650862221909.
If you have the affected graft and notice separation, stop using it immediately. There is no specific remedy stated in the recall notice.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1980-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1980-2024 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.