Reported Feb 11, 2026 · Ongoing
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
- Material Number (UPN)M00553660
- Lot codes and dates
- Material Number (UPN)M00553680
- UDI-DI8714729951179
- Lot Numbers
557 of 557 codes
359610063596100735962524359673793596852035968521359685973596859835971077359710783597107935972100359822723598227335982274359822753598227635982277359822783598227935982420359824243598242535985313359853143599361935993720359937213610976136109763361097643610976536109766361113143611131536118993361189943612206636122067361220753613280136132802361328033613280436134972361440583614405936144120361441213617447536174476361780053618758836187589361876873618768836188887361888883618888936194446
- Amount recalled
- 557 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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