Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes and product IDs. Consumers should check their device details.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atr:ium Medical is recalling certain ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation creates a notable gap between the two parts, which could lead to 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 compromise the graft's function during medical procedures, leading to potential complications.
Patients using the ADVANTA VXT vascular grafts with the specific model codes (6X40, 1GDS, FH, STR-SW) are likely affected. Medical professionals who have installed these grafts are at higher risk.
Check for the model codes: 6X40, 1GDS, FH, STR-SW on the ADVANTA VXT vascular graft. The product code is 22059 and UDI-DI is 00650862220599.
Identify the model codes (6X40, 1GDS, FH, STR-SW) and product code 22059 on the vascular graft.
The recall record does not specify if the product is safe when used correctly.
Check for the model codes: 6X40, 1GDS, FH, STR-SW and product code 22059 on the vascular graft.
The recall record does not provide specific action steps for affected products.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1963-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1963-2024 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.
