BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0141-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0141-2026
    Event Number
    97603
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    JCW
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 11, 2025
    Posted
    October 10, 2025
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    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.

    Action

    On September 11, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: For implanted devices: If the device is working properly, no action is required. Further evaluation is recommended for patients who were implanted with an affected device AND are having difficulty inflating or deflating the device. - Check inventory for affected product and return any unused devices. Immediately cease further distribution or use of any unused affected devices. Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Please provide Boston Scientific with details of any affected devices that have been transferred to another organization.

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    0 units