Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes; 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.
Atr: Atrium Medical is recalling specific ADVANTA VXT vascular graft models due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation creates a 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 parts. This separation could cause the graft to malfunction during medical procedures, potentially leading to complications.
Patients using the ADVANTA VXT vascular grafts with model codes 8X40, 1GDS, NH, STR-TW are affected. Medical professionals performing procedures with these grafts are at higher risk.
Check for the model codes 8X40, 1GDS, NH, STR-TW on the ADVANTA VXT vascular grafts. The product code is 22170 and UDI-DI is 00650862221701.
Inspect the graft for a gap between the Slider GDS Swivel Rod and Swivel Core.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating a gap between the two parts.
Check for separation between the Slider GDS Swivel Rod and Swivel Core. If separation occurs, stop using the graft immediately.
Affected products have model codes 8X40, 1GDS, NH, STR-TW with product code 22170 and UDI-DI 00650862221701.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1974-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1974-2024 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.