Medtronic Abre Venous Stent Recall: Potential Sterile Package Breach
Medtronic recalls specific Abre Venous Self-expanding Stent Systems due to potential sterile package breach. Affected product numbers include AB9U14080090, AB9U18100090, and AB9G14100090. No remedy is specified in the recall notice.
Recall notice
There is a potential for sterile package breach.
Contact the company
What happened, in plain English
Medtronic is recalling three specific models of Abre Venous Self-expanding Stent Systems because there's a potential for the sterile packaging to breach. This could lead to contamination of the device, but the recall does not include a remedy or action for consumers. Read more at govinfonow.com/recall/56149-medtronic-abre-venous-stent-recall-potential-sterile-package-breach.
Source Summary by GovInfoNow · govinfonow.com/recall/56149-medtronic-abre-venous-stent-recall-potential-sterile-package-breach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1317-2024
Cite this page
“Medtronic Abre Venous Stent Recall: Potential Sterile Package Breach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56149-medtronic-abre-venous-stent-recall-potential-sterile-package-breach. Based on FDA recall #Z-1317-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1317-2024%22&limit=1).
Why it’s dangerous
The sterile packaging could breach, potentially contaminating the stent with bacteria or other harmful substances. This contamination could lead to infections or other complications during or after the procedure.
Who’s affected
Patients who have received one of the recalled stent models during surgery are likely affected. Medical professionals using these stents for procedures are at risk if the packaging breaches.
How to tell if you have this one
Check the product number on the stent package: AB9U14080090, AB9U18100090, or AB9G14100090. Also look for the batch number (B456626, B456811, or B460542) to confirm if it's affected.
- Brand
Medtronic- Category
Medical device
What to do — step by step
Check Product Number
Identify the product number on the stent package to see if it matches the recalled models: AB9U14080090, AB9U18100090, or AB9G14100090.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.” 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 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1317-2024 (February 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1317-2024 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.