BEUDAMED
    FDA Enforcement Class I Ongoing

    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

    Recall: Z-1160-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1160-2026
    Event ID
    98237
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    February 11, 2026
    Initiation Date
    December 19, 2025
    Classification Date
    February 5, 2026
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;

    Reason

    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.

    Code Info

    Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043,

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

    Quantity

    59 units