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 and Electrocautery-Enhanced Delivery System
- Model numbers
- Material Number (UPN): M00553680, UDI-DI: 8714729951179, Lot Numbers: 35961006, 35961007, 35962524, 35967379, 35968520, 35968521 +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 and Electrocautery-Enhanced Delivery System is used in various medical procedures to assist with stent placement. Patients may rely on this device for effective treatment of certain medical conditions.
Why This Is Dangerous
The stent may fail to deploy or expand as intended, leading to complications during medical procedures. This increases the time needed for the procedure and may require additional medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the AXIOS Stent may face delays in treatment and potential additional procedures, increasing healthcare costs and risks.
Practical Guidance
How to identify if yours is affected
- Check the material number (M00553660) and lot numbers against the recall list.
- Consult with your healthcare provider regarding your stent's status.
- Ensure to stop using the stent immediately if it is affected.
Where to find product info
The material number and lot numbers can usually be found on the product packaging or accompanying documentation.
What timeline to expect
Refund or replacement processing may take 4-6 weeks after submission.
If the manufacturer is unresponsive
- Document all correspondence with the company regarding the recall.
- Contact your healthcare provider for further assistance if the company is unresponsive.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Consult with healthcare providers about alternative devices.
Documentation advice
Keep all purchase receipts and any communications with the manufacturer for your records.
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Product Details
The recalled product is the AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm, Material Number (UPN): M00553660. It was distributed worldwide, including the US and Puerto Rico, and had multiple lot numbers.
Key Facts
- Class I recall
- Increased deployment issues
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Safety Guide
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