BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2618-2025 · Initiated August 28, 2025

    Recall

    Recall Number
    Z-2618-2025
    Event Number
    97529
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FGE
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 28, 2025
    Posted
    September 23, 2025
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    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.

    Action

    On August 28, 2025 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Instructions: 1. Immediately cease further distribution or use of any remaining affected devices. Segregate the units in a secure place until they can be returned. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. 4. Return affected devices.

    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