Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have Product Code 22212 and UDI-DI 00650:00650862222128. 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.
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of Slider GDS Swivel Rod separation. This separation could create a gap between the rod and core, potentially causing complications during medical procedures.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a noticeable gap. This separation may lead to complications during medical procedures if the gap affects the graft's function.
Patients using the ADVANTA VXT vascular grafts for medical procedures are affected. Those with the specific product code 22212 and UDI-DI 00650862222128 are most at risk.
Check for Product Code 22212 and UDI-DI 00650862222128 on the device. The ADVANTA VXT vascular grafts are sold under the model names 6X50, 1GDS, FH, STR-TW.
Inspect the Slider GDS Swivel Rod for separation from the Swivel Core and a gap between the two pieces.
Product Code: 22212
UDI-DI: 00650862222128
Check for Product Code 22212 and UDI-DI 00650862222128 on the device.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1983-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1983-2024 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.
