BEUDAMED
    FDA Enforcement Class II Ongoing

    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

    Recall: Z-0141-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0141-2026
    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

    LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

    Reason

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

    Code Info

    1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    0 units