Atrium Medical recalls ADVANTA VXT vascular grafts (model 4-6X45, 1GDS) due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between components.
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 grafts because users have reported the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap. This could lead to complications if the graft fails during use.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two parts. This separation might cause the graft to malfunction or fail during medical procedures, potentially leading to complications.
Patients who have received the specific ADVANTA VXT vascular graft model (4-6X45, 1GDS) from Atrium Medical are most at risk. Healthcare providers using this model should check if their patients have the recalled item.
Check for the product code 22114 and UDI-DI 00650862221145 on the vascular graft. The model is labeled as ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW.
Look for the product code 22114 and UDI-DI 00650862221145 on the vascular graft.
The recall is based on reported separations creating gaps, but no injuries have been reported. The risk level is low.
Check for the product code 22114 and UDI-DI 00650862221145 on the vascular graft. The model is ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW.
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-1993-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1993-2024 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.