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Medical device recall · FDA · Published August 25, 2021

Atrium Medical Corporation recalls Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial

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.

🇺🇸 FDA recall #Z-2589-2021Medical deviceAtrium Medical ›
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Contact the company & request your remedy

Recalling firmAtrium Medical Corporation40 Continental Blvd, N/A · Merrimack, NH 03054-4332
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

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. Read more at govinfonow.com/recall/61896-atrium-advanta-vxt-vascular-graft-recall-risk-of-mismatched-graft.

Source Summary by GovInfoNow · govinfonow.com/recall/61896-atrium-advanta-vxt-vascular-graft-recall-risk-of-mismatched-graft · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2589-2021

Cite this page

“Atrium ADVANTA VXT Vascular Graft Recall: Risk of Mismatched Graft.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61896-atrium-advanta-vxt-vascular-graft-recall-risk-of-mismatched-graft. Based on FDA recall #Z-2589-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2021%22&limit=1).

Why it’s dangerous

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.

Who’s affected

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.

How to tell if you have this one

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.

  • Brand
    Atrium Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the product name, part number, and UDI to confirm if your graft is affected.

✎ GovInfoNow

Questions people ask

Why is this graft being recalled?

The product package may contain a graft without the radial support ring (helix) that is required for proper function during arterial procedures.

What should I do if I have this graft?

The recall does not specify a remedy, so contact Atrium Medical for further instructions.

Are there specific lot numbers affected?

Yes, the affected lot numbers range from 458755001 to 458755030.

Take action

Contact Atrium Medical

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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Where this comes from

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.

  • Official source: FDA Recall #Z-2589-2021 (August 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2589-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA