Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes and may need replacement due to potential gaps 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.
Atr:ium Medical is recalling specific ADVANTA VXT vascular grafts after reports of the Slider GDS Swivel Rod separating from the Swivel Core, creating a noticeable gap. This separation could lead to complications during medical procedures.
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 during medical procedures, potentially leading to complications.
Patients using the ADVANTA VXT vascular grafts with model codes 6X50, 1GDS, NH, STR-TW are affected. Medical professionals performing procedures with these grafts are at higher risk.
Check for model codes 6X50, 1GDS, NH, STR-TW on the ADVANTA VXT vascular grafts. The product code is 22175 and UDI-DI is 00650862221756.
Verify the model codes 6X50, 1GDS, NH, STR-TW on the vascular graft to confirm if it is affected.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a noticeable gap between the two parts.
Check the model codes on the product to see if it is affected; if so, contact Atrium Medical for further instructions.
The recall record does not specify a 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-1975-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1975-2024 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.