BEUDAMED
    FDA Enforcement Class II Terminated

    MISAGO RX Self Expanding Peripheral Stem

    Recall: Z-0669-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0669-2017
    Event ID
    75370
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    August 4, 2016
    Classification Date
    November 29, 2016
    Termination Date
    October 19, 2017
    Address
    2101 Cottontail Ln, Somerset, NJ, 08873-1277, United States

    Description

    MISAGO RX Self Expanding Peripheral Stem

    Reason

    During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

    Code Info

    150401 150429 150713 150821 150923 151009 160314 150413 150501 150708 150824 150915 151013 151111 150415 150515 150701 150716 150902 151005 151106 150407 150514 150707 150827 151008 151109 160509 150406 150501 150713 150716 150825 151001 151102 160315 160509 150410 150710 150831 150909 151007 151012 151014 151103 151208 150417 150429 150717 150910 151002 151102 160510 150408 150429 150701 150717 150831 151013 151103 160512 150409 150430 150518 150703 150706 150903 150914 151005 150331 150430 150708 150714 150904 150910 151001 151102 150414 150429 150715 150903 151005 151029 160323 150416 150518 150715 150908 150915 151002 151106 160328 150401 150430 150716 150828 151006 150403 150514 150717 150901 150909 151012 150408 150430 150713 150907 151001 150402 150512 150713 150907 151001

    Distribution

    Nationwide

    Quantity

    7,965 units