Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- 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
- Boston Scientific
- Product type
- Stent Delivery System
- Model numbers
- Material Number (UPN): M00553680, UDI-DI: 191506008086, Lot Numbers: 35950784, 35960771, 35960772, 36156260, 36156261, 36165653 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: N/A
About This Product
The AXIOS Stent is a medical device used to facilitate procedures involving stent placement in various medical treatments. Healthcare providers typically use it during endoscopic interventions.
Why This Is Dangerous
The defect in deployment and expansion of the stent can lead to procedural complications, potentially requiring additional medical interventions, which may be invasive.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for patients who need immediate stent placement, as it could delay necessary medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the Material Number: M00553680.
- Verify the UDI-DI: 191506008086.
- Look for the lot numbers listed in the recall notice.
Where to find product info
You can find the Material Number on the product packaging or accompanying documentation provided by the manufacturer.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Boston Scientific directly for assistance.
- Reach out to the FDA for guidance on next steps.
How to prevent similar issues
- Inquire about the latest device safety reports before purchasing medical devices.
- Consult with healthcare professionals about the latest recalls and safety alerts.
Documentation advice
Keep records of all communications, receipts, and any relevant documentation regarding the recalled product.
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Product Details
The recalled product is the AXIOS Stent and Electrocautery-Enhanced Delivery System, Material Number M00553680. The recall includes 39 units distributed globally, including the U.S. and Puerto Rico, as well as various countries in Europe, Asia, and South America.
Key Facts
- 39 units recalled worldwide
- Deployment issues could require additional surgery
- Immediate action required: stop using the device
- Contact Boston Scientific for return instructions
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Safety Guide
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