BEUDAMED
    FDA Enforcement Class II Terminated

    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.

    Recall: Z-1429-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1429-2021
    Event ID
    87539
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 21, 2021
    Initiation Date
    March 5, 2021
    Classification Date
    April 15, 2021
    Termination Date
    January 5, 2023
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.

    Reason

    The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

    Code Info

    UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23

    Distribution

    Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL, KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland

    Quantity

    52 devices