Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes and may pose separation risks.
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 due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation could create a gap between the pieces, potentially causing complications during medical procedures.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two pieces. This separation may lead to complications during medical procedures if the graft is still in use.
Patients using the ADVANTA VXT vascular grafts with model codes 8X70, 1GDS, NH, STR-TW are affected. Medical professionals who have implanted these grafts are most at risk.
Check for the model codes 8X70, 1GDS, NH, STR-TW on the ADVANTA VXT vascular grafts. The product code is 22187 and UDI-DI is 00650862221879.
Verify the model codes 8X70, 1GDS, NH, STR-TW on the vascular graft to confirm if it is affected.
The recall is based on reported separations, but the product may still be safe if no separation has occurred. Consult your healthcare provider for specific guidance.
The recall does not specify a remedy, so contact Atrium Medical directly for further instructions.
Look for model codes 8X70, 1GDS, NH, STR-TW on the vascular graft. The product code is 22187 and UDI-DI is 00650862221879.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1979-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1979-2024 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.
