BEUDAMED
    FDA Enforcement Class II Ongoing

    TENACIO Pump without InhibiZone; UPN: 72404420;

    Recall: Z-0139-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0139-2026
    Event ID
    97603
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 11, 2025
    Classification Date
    October 10, 2025
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    Description

    TENACIO Pump without InhibiZone; UPN: 72404420;

    Reason

    The potential for devices to experience inflation and/or deflation performance issues or difficulties.

    Code Info

    UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    0 units