BEUDAMED
    FDA Enforcement Class II Ongoing

    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

    Recall: Z-0140-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0140-2026
    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

    CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

    Reason

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

    Code Info

    1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;

    Distribution

    Worldwide distribution - US Nationwide and the country of Canada.

    Quantity

    1 unit