Atrium Medical recalls ADVANTA VXT vascular grafts (model 4-7X45, 1GDS) due to reported separation of Slider GDS Swivel Rod from Swivel Core, creating a gap between pieces.
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 (model : 4-7X45, 1GDS) because users have reported the Slider GDS Swivel Rod separating from the Swivel Core, creating a gap between the two parts. This separation could potentially cause complications during medical procedures.
The hazard involves the Slider GDS Swivel Rod potentially separating from the Swivel Core, creating a gap between the two components. This separation could lead to complications during medical procedures if the gap affects the graft's function or integrity.
Patients using the recalled ADVANTA VXT vascular grafts for medical procedures are most at risk. The specific model numbers (4-7X45, 1GDS) indicate this recall targets certain surgical implants.
Check for the product code 22115 and UDI-DI 00650862221152 on the vascular graft. The model numbers 4-7X45 and 1GDS indicate the specific recalled items.
Verify the product code 22115 and UDI-DI 00650862221152 on the vascular graft to confirm if it's recalled.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between the two pieces.
The affected models are 4-7X45 and 1GDS with product code 22115 and UDI-DI 00650862221152.
The recall record does not specify any 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-1994-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1994-2024 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.
