FDA recall, , Moderate risk
Medtronic Abre Venous Self-Expanding Stent System
The Abre Venous Self-Expanding Stent System may have a Nitinol anomaly causing reduced stent diameter and radial force, potentially leading to migration.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Inc, of Plymouth, Minnesota, recalled the Abre Venous Self-Expanding Stent System on December 4, 2025. The FDA added the recall to its Enforcement Report on January 15, 2026. The stents may have a Nitinol anomaly that reduces stent diameter and radial force when deployed, which may result in stent migration.
The product was distributed nationwide in the US and worldwide, including Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number, UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Abre Venous Self-Expanding Stent System
- Model number
- AB9G14120090
- AB9G12100090
- AB9G14080090
- AB9G12080090
- AB9U12060090
- AB9U14100090
- AB9U14080090
- AB9U12080090
- AB9U14060090
- AB9G14100090
- AB9G12060090
- UDI-DI
- 00763000547332
- 00763000547271
- 00763000547318
- 00763000547264
- 00643169796225
- 00643169796300
- 00643169796294
- 00643169796232
- 00643169796287
- 00763000547325
- 00763000547257
- Lot code
- C112511
- C113253
- C113795
- C117416
- C117482
- C121084
- C123953
- C133327
- C133329
- C134478
- C138060
- C150325
Recall details
- Company began the recall
- Sold in
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, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.
- Company
- Medtronic IncPlymouth, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98157
- Recall number
- Z-1098-2026
All recalls from Medtronic Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
