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): M00553530, UDI-DI: 8714729904557, Lot Numbers: 35985705, 35986358, 36147098, 36147222, 36165642, 36176423 +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
April 13, 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 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System is used in medical procedures to assist with the delivery of stents. It is typically used in patients requiring internal support for ducts or vessels during endoscopic procedures.
Why This Is Dangerous
The primary hazard stems from difficulties in deploying and expanding the stent, which can lead to complications. Failure of the stent to deploy may necessitate additional medical interventions and prolong the procedure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause significant delays in medical procedures requiring stent placement, potentially affecting patient outcomes and increasing healthcare costs.
Practical Guidance
How to identify if yours is affected
- Check the Material Number (UPN) for M00553530.
- Verify the lot number against the provided list from your device.
- Consult your healthcare provider if you are unsure about the status of your stent.
Where to find product info
Information can typically be found on the product packaging, device label, or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after initiating the request.
If the manufacturer is unresponsive
- Contact Boston Scientific directly for follow-up.
- Reach out to your healthcare provider for assistance.
How to prevent similar issues
- Inquire about the recall status of medical devices before use.
- Verify the safety and effectiveness of similar devices with your healthcare provider.
Documentation advice
Keep records of your stent details, any correspondence with the manufacturer, and medical documentation regarding the recall.
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Product Details
The affected product is the *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm, with Material Number (UPN): M00553530. The recall includes lot numbers ranging from 35985705 to 36301620. The product was distributed worldwide, including across the United States and several countries in Europe, Asia, and Latin America.
Key Facts
- Recall Date: December 19, 2025
- Quantity Recalled: 150 units
- Class I Recall
- Worldwide distribution including the US and Puerto Rico
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Safety Guide
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