Unrated Medical device recall · FDA · Published December 4, 2025

Medtronic Abre Venous Stent Recall: Nitinol Anomaly May Cause Stent Migration

Medtronic recalls specific Abre Venous Self-Expanding Stent models due to a Nitinol anomaly that may reduce stent diameter and cause migration. Affected models include AB9G14120090 and others listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1098-2026Medical device Medtronic ›

Recall notice

Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.

Take action

Contact the company

Recalling firmMedtronic Inc4600 Nathan Ln N · Plymouth, MN 55442-2890

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain Abre Venous Self-Expanding Stent models because a defect in the Nitinol material can cause the stent to become narrower and move from its intended position. This could lead to complications in blood flow and require additional medical intervention. Read more at govinfonow.com/recall/50531-medtronic-abre-venous-stent-recall-nitinol-anomaly-may-cause-stent.

Source Summary by GovInfoNow · govinfonow.com/recall/50531-medtronic-abre-venous-stent-recall-nitinol-anomaly-may-cause-stent · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1098-2026

Cite this page

“Medtronic Abre Venous Stent Recall: Nitinol Anomaly May Cause Stent Migration.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50531-medtronic-abre-venous-stent-recall-nitinol-anomaly-may-cause-stent. Based on FDA recall #Z-1098-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1098-2026%22&limit=1).

The FDA announced on Dec. 4, 2025, that Medtronic Inc. is recalling Abre Venous Self-Expanding Stent Systems due to a Nitinol anomaly that may reduce stent diameter and radial force. The recall affects 442 units distributed worldwide.

How to tell if you have it

Brand: Medtronic
Product: Abre Venous Self-Expanding Stent System
Model numbers: AB9G14120090, AB9G12100090, AB9G14080090, AB9G12080090, AB9U12060090, AB9U14100090, AB9U14080090, AB9U12080090, AB9U14060090, AB9G14100090, AB9G12060090
UDI-DI (GTIN): 00763000547332, 00763000547271, 00763000547318, 00763000547264, 00643169796225, 00643169796300, 00643169796294, 00643169796232, 00643169796287, 00763000547325, 00643169796300, 00763000547257
Serial/Lot numbers: C112511, C113253, C113795, C117416, C117482, C121084, C123953, C133327, C133329, C134478, C138060, C150325
Units affected: 442

The hazard

The stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. The issue may result in stent migration.

Context

GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Other recent recalls of similar products include Boston Scientific AXIOS Stent Recall (2025-12-19), Microvention LVIS Stent Device Recall (2026-04-06), and Medline Neuro Angio Pack Kits Recall (2025-11-26).

How to tell if you have this one

Check the model numbers on the stent packaging or device label for AB9G14120090, AB9G12100090, AB9G14080090, AB9G12080090, AB9U12060090, or other listed numbers. Also look for the UDI-DI (GTIN) codes provided in the recall notice.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Model Numbers
Review the stent model numbers on the device label or packaging to see if they match the recalled models listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia,…” 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 published this recall 48 days after the firm started it.

Dec 4, 2025Firm started the recall
Jan 15, 2026FDA classified it Class II
Jan 21, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/50531-medtronic-abre-venous-stent-recall-nitinol-anomaly-may-cause-stent">Medtronic Abre Venous Stent Recall: Nitinol Anomaly May Cause Stent Migration (GovInfoNow)</a>

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-1098-2026 (December 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1098-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.