BEUDAMED
    FDA Recall Open, Classified

    AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

    Recall: Z-1026-2025 · Initiated December 20, 2024

    Recall

    Recall Number
    Z-1026-2025
    Event Number
    96049
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    KNS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 20, 2024
    Posted
    January 29, 2025
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660

    Reason

    Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

    Action

    Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.

    Distribution

    Nationwide including Puerto Rico Foreign: To be provided

    Quantity

    1399 units; 20 units (OUS)