BEUDAMED
    FDA Enforcement Class II Terminated

    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

    Recall: Z-1617-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1617-2013
    Event ID
    65506
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2013
    Initiation Date
    June 19, 2013
    Classification Date
    June 28, 2013
    Termination Date
    February 7, 2014
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

    Reason

    Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.

    Code Info

    Lot # 15832314L

    Distribution

    Distributed in the states of MN, FL, and UT.

    Quantity

    10 units