Atrium Medical recalls specific ADVANTA VXT vascular grafts that may have a mismatched graft without the radial support ring, potentially causing complications during arterial procedures.
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Atrium Medical is recalling certain ADVANTA VXT vascular grafts that could have a mismatched graft without the radial support ring. This could lead to complications during arterial procedures if used improperly.
The grafts may lack the radial support ring (helix) that is supposed to be present, which could lead to improper function during arterial procedures. This mismatch might cause complications such as blockages or leaks in the vascular system.
Patients undergoing arterial vascular reconstruction, segmental bypass, or arteriovenous vascular access procedures are likely affected. Medical professionals using these grafts for surgical procedures are at the highest risk.
Check for the product name 'Atrium ADVANTA VXT Vascular Graft', part number 22059, and unique device identifier (UDI) 00650862220599. The affected lot numbers include 458755001 through 458755030.
Verify the product name, part number, and UDI to confirm if your graft is affected.
The product package may contain a graft without the radial support ring (helix) that is required for proper function during arterial procedures.
The recall does not specify a remedy, so contact Atrium Medical for further instructions.
Yes, the affected lot numbers range from 458755001 to 458755030.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2589-2021 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-2589-2021 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.
