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: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 could create a gap between the two parts, potentially causing 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 lead to complications during vascular procedures if the gap affects the graft's function.
Patients using the ADVANTA VXT vascular grafts with model codes 8X50, 1GDS, FH, STR-SW are affected. Medical professionals performing procedures with these grafts are most at risk.
Check for model codes 8X50, 1GDS, FH, STR-SW on the ADVANTA VXT vascular grafts. Product code 22064 and UDI-DI 00650862220643 are also identifiers for affected units.
Inspect the Slider GDS Swivel Rod for separation from the Swivel Core and any notable gaps between the two parts.
Affected models include 8X50, 1GDS, FH, STR-SW for the ADVANTA VXT vascular graft.
The recall record does not mention a remedy or fix for the separation issue.
Check for model codes 8X50, 1GDS, FH, STR-SW and product code 22064 with UDI-DI 00650862220643.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1967-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1967-2024 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.