BEUDAMED
    FDA Enforcement Class II Ongoing

    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

    Recall: Z-0531-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0531-2025
    Event ID
    95608
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 28, 2024
    Classification Date
    November 25, 2024
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    Description

    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O

    Reason

    Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

    Code Info

    UPN Number: 72400024. GTIN Number: 00878953000626. Lot Numbers: 32500739, 32500821, 32500820. Serial Numbers: 1100366088, 1100366115, 1100366089, 1100366116, 1100366090, 1100366117, 1100366091, 1100366118, 1100366092, 1100366119, 1100366093, 1100366120, 1100366094, 1100366121, 1100366095, 1100366122, 1100366096, 1100366123, 1100366097, 1100366144, 1100366098, 1100366145, 1100366099, 1100366146, 1100366100, 1100366147, 1100366101, 1100366148, 1100366102, 1100366149, 1100366103, 1100366150, 1100366104, 1100366151, 1100366105, 1100366152, 1100366106, 1100366153, 1100366107, 1100366154, 1100366108, 1100366155, 1100366109, 1100366156, 1100366110, 1100366157, 1100366111, 1100366158, 1100366112, 1100366159, 1100366113, 1100366160, 1100366114. Expiration Date: 09/23/2028

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.

    Quantity

    52 units