Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes; contact for remedy.
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 notable gap between the two parts, which 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 complications during medical procedures if the graft is still in use.
Patients using the ADVANTA VXT vascular grafts with model codes 8X70, 1GDS, FH, STR-TW are affected. Medical professionals who have implanted these grafts are most at risk.
Check for the model codes 8X70, 1GDS, FH, STR-TW on the ADVANTA VXT vascular grafts. The product code is 22222 and UDI-DI is 00650862222227.
Verify the model codes 8X70, 1GDS, FH, STR-TW on the vascular graft to confirm if it is affected.
The recall reports separation of the Slider GDS Swivel Rod from the Swivel Core, but the official notice does not specify if this causes serious injury or death.
The recall record does not provide a remedy, so contact Atrium Medical for further instructions.
Check for the model codes 8X70, 1GDS, FH, STR-TW on the vascular graft. The product code is 22222 and UDI-DI is 00650862222227.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1988-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1988-2024 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.
