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): M00553520, UDI-DI: 8714729904540, Lot Numbers: 36067957, 36067958, 36067959, 36067960, 36067961, 36099410 +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 HOT AXIOS Stent is designed for use in endoscopic procedures to facilitate drainage. It is often used in patients requiring biliary or gastrointestinal interventions.
Why This Is Dangerous
Deployment issues can lead to complications, including the inability to properly position the stent, which may necessitate additional surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare procedures, potentially leading to delays and increased patient risk during stent placement.
Practical Guidance
How to identify if yours is affected
- Check the material number M00553520.
- Verify if your stent's lot number is among those listed in the recall.
- Consult your healthcare provider for confirmation.
Where to find product info
Lot numbers and material numbers can typically be found on the packaging or product documentation.
What timeline to expect
Refund processing may take approximately 4-6 weeks after the manufacturer receives the returned product.
If the manufacturer is unresponsive
- Contact Boston Scientific customer service again.
- Escalate the issue to your healthcare provider for assistance.
- Document all communications with the manufacturer.
How to prevent similar issues
- Look for stents with updated safety certifications.
- Ensure products are FDA-approved before use.
- Consult with healthcare providers about the latest device recalls.
Documentation advice
Keep records of your purchase, correspondence with the manufacturer, and any medical documentation related to your use of the stent.
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Product Details
The recalled product is the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 6mm x 8mm, Material Number M00553520. It was distributed worldwide, including the U.S. and Puerto Rico. Specific lot numbers affected include 36067957 through 36154529.
Key Facts
- Deployment and expansion issues reported
- Potential for serious complications
- Stop use immediately
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Safety Guide
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