Lower riskMedical device recall · FDA · Published August 25, 2021
Atrium ADVANTA VXT Vascular Graft Recall: Risk of Mismatched Graft
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.
“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).
Atrium Medical Corporation voluntarily recalled its Atrium ADVANTA VXT Vascular Graft, Part No. 22059, because packages may contain a mismatched graft lacking the radial support ring identified in labeling, according to the FDA on Aug. 25, 2021.
Distribution: US Nationwide distribution in the state of Florida and the countries of South Korea and Poland
The hazard
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling, according to the FDA.
Context
GovInfoNow's records show Atrium Medical Corporation has 16 other recalls on record since 2017-11-22. Other recent recalls of similar products include LeMait: Artegraft Vascular Graft Recall Due to Labeling Mix-Up (2026-02-10), Intervascular Cardioroot Vascular Grafts May Fail Water Permeability Test (2026-08-12), and Berlin Heart Recalls Pediatric VAD Blood Pump Valves Due to Expiration Date Mismatch (2026-04-24).
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
Check Product Details
Verify the product name, part number, and UDI to confirm if your graft is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.