Quick Facts at a Glance
- Recall Date
- December 4, 2025
- Hazard Level
- HIGH
- Brand
- Medtronic
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic
- Product type
- Self-Expanding Stent
- Model numbers
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Abre Venous Self-Expanding Stent System is a medical device used to treat venous obstructions. Patients typically receive this stent to improve blood flow in affected veins.
Why This Is Dangerous
The Nitinol anomaly can cause the stent to reduce in diameter when deployed, which compromises its effectiveness and can lead to migration from the intended location.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this stent face potential risks that may require medical intervention, making this recall critical for ensuring patient safety.
Practical Guidance
How to identify if yours is affected
- Check model numbers on the device packaging or documentation.
- Verify if the stent falls within the recalled model numbers listed above.
- Consult your healthcare provider for confirmation.
Where to find product info
Model numbers and lot numbers can typically be found on the device packaging or accompanying documentation.
What timeline to expect
Expect a response from the manufacturer within 4-6 weeks regarding the recall process and refunds.
If the manufacturer is unresponsive
- Contact Medtronic directly for updates.
- Document all communication attempts with the manufacturer.
How to prevent similar issues
- Always check for current recalls on medical devices before use.
- Consult with your healthcare provider about the most recent safety information.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any medical records related to the stent.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves the Abre Venous Self-Expanding Stent System with model numbers AB9G14120090, AB9G12100090, AB9G14080090, and others. The stents were distributed globally, including in the U.S. and several countries in Europe and Asia. The price range is not specified.
Key Facts
- Recall date: December 4, 2025
- Total units recalled: 442
- Affected countries include the US, UK, and Australia
- Immediate action required by users
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
