BEUDAMED
    FDA Enforcement Class II Ongoing

    Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

    Recall: Z-2618-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2618-2025
    Event ID
    97529
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    August 28, 2025
    Classification Date
    September 23, 2025
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

    Reason

    The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

    Code Info

    Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

    Distribution

    US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.

    Quantity

    156 units