BEUDAMED
    FDA Enforcement Class II Terminated

    Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

    Recall: Z-3043-2017 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3043-2017
    Event ID
    77820
    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
    August 23, 2017
    Initiation Date
    June 15, 2017
    Classification Date
    August 16, 2017
    Termination Date
    July 22, 2020
    Address
    100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States

    Description

    Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

    Reason

    Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

    Code Info

    Serial Numbers: (a) 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051, 20127928, 20159518, 20202728, 20206930, 20242335, 20285571, 20309573, 20309574, 20336380, 20394218, 20423644, 20423645, 20456071, 20481170, 20534557 (b) 19640750, 19667072, 19704551, 19755302, 19755307, 19785021, 19808183, 20030825, 20060033, 20087896, 20117909, 20159601, 20171449, 20206929, 20233700, 20256035, 20279769, 20303751, 20336385, 20336386, 20364928, 20364929, 20364930, 20423650, 20472532, 20493563, 20507373, 20534581 (c) 20157078, 19623019, 19755304, 20056496, 20146417, 20264032, 20456079 (d) 19594194, 19717352, 19808180, 20121252, 20223176, 20336387, 20394350, 20534582

    Distribution

    Worldwide

    Quantity

    305,779 units