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): M00553560, UDI-DI: 8714729951100, Lot Numbers: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165 +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 designed for use in endoscopic procedures. It helps facilitate the placement of stents for various medical conditions.
Why This Is Dangerous
Deployment difficulties may prevent the stent from functioning as intended, potentially leading to extended medical procedures or the need for surgical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may lead to increased procedure times and the risk of complications for patients, necessitating immediate cessation of use.
Practical Guidance
How to identify if yours is affected
- Check the material number: M00553560.
- Verify lot numbers against the recalled list.
- Consult your healthcare provider for assistance.
Where to find product info
The material number and lot numbers can be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Boston Scientific customer service directly.
- File a complaint with the FDA if the issue is not resolved.
How to prevent similar issues
- Look for stents with updated safety certifications.
- Discuss any stent options with your healthcare provider.
- Ensure all medical devices are FDA approved.
Documentation advice
Keep copies of any correspondence with the manufacturer and retain any receipts or documentation related to the stent.
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Product Details
The recall involves the *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, Material Number (UPN): M00553560. It was distributed worldwide, including the US and several other countries. The stent dimensions are 20mm x 10mm.
Key Facts
- Class I recall due to high risk
- Stop using the device immediately
- Contact healthcare provider for instructions
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Safety Guide
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