BEUDAMED
    FDA Enforcement Class II Terminated

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    Recall: Z-1525-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1525-2015
    Event ID
    71021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    April 17, 2015
    Classification Date
    April 27, 2015
    Termination Date
    December 10, 2015
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006, United States

    Description

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    Reason

    The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

    Code Info

    Lot No. 17147443M, 17177237M, 17196045M, 17142745M, 17176185M, 17191133M, 17177957M, 17162927M, 17163734M, 17159129M, 17157116M, 17144954M, 17192170M, 17192723M, 17173428M, 17174967M, 17174968M, 17194186M, 17194707M, 17153400M, 17154595M, 17176186M, 17142888M, 17167809M, 17167282M, 17158235M, 17159407M, 17151134M, 17154141M, 17176477M, 17176478M, 17172465M, 17145731M, 17146665M, 17172058M.

    Distribution

    US nationwide distribution.

    Quantity

    503 units