BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0531-2025 · Initiated October 28, 2024

    Recall

    Recall Number
    Z-0531-2025
    Event Number
    95608
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    EZY
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    October 28, 2024
    Posted
    November 25, 2024
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    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)

    Action

    Boston Scientific notified their consignees on about 10/28/2024 via letter. Consignees were instructed to immediately discontinue use and segregate the affected products, notify all personnel that need to be aware, notify customers if further distributed, arrange for the return of affected product and complete and return the Reply Verification Tracking Form (RVtF).

    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