BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    Recall: Z-1223-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1223-2020
    Event ID
    84585
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microvention, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    November 24, 2019
    Classification Date
    February 13, 2020
    Termination Date
    April 20, 2021
    Address
    35 Enterprise, Aliso Viejo, CA, 92656-2601, United States

    Description

    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    Reason

    The devices may be missing the implant coil.

    Code Info

    Catalog/lot numbers: 45-451015 - 190410589; 45-451020- 19030456J, 19041056C, 19041756Y, 190422549, and 190422573; 45-451215 -190410569; 45-451220 -19040853N; 45-451230 -19041554R; 45-451520 -19030654N, 190408565, 190410588, and 190422572; 45-451530 -19030456L, 190408569, 19041056A, 190415571, 19041756Z, 190417599, 19042656G, and 19050254X; 45-452020 -19030456N, 19030654L, 19030655W, 19040856A, and 19041552H; 45-452030 - 19041058A, 19041554U, and 19042656H; 45-450410 - 19030456C, 19030655V, 19041058F, and 190422575; 45-450415 - 190422574; 45-450405 - 19030453C, 19030456B, and 19042254B; 45-450610 - 19030456E, 19030654W, 190410568, and 19041058E; 45-450615 - 19030456F, 190401568, 19041058C, and 19041556Y; 45-450620 - 19030453J and 19030655N; 45-450815 - 19030456G, 19030654U, 19050253U, and 19050254Z; 45-450820 - 19030453K,19030456H, 19030654R, 19030655G, 19030655H, 19050253V, 19050254Y, 19050657T, and 19051058C; and MV-AZ52030HD - 190405564.

    Distribution

    The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

    Quantity

    392 units