BEUDAMED
    FDA Recall Terminated

    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

    Recall: Z-1133-2018 · Initiated December 20, 2017

    Recall

    Recall Number
    Z-1133-2018
    Event Number
    79529
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FBN
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 20, 2017
    Terminated
    December 13, 2019
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

    Reason

    Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

    Action

    The notification letter requests the consignee to identify and return the affected product along with the response form. Distributors are asked to share the recall information to the customer level. 12/20/2017 by mail.

    Distribution

    Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru

    Quantity

    5026