BEUDAMED
    FDA Enforcement Class II Terminated

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    Recall: Z-0139-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0139-2015
    Event ID
    69532
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    October 19, 2014
    Classification Date
    October 27, 2014
    Termination Date
    October 6, 2015
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

    Reason

    The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.

    Code Info

    Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603 All Lots manufactured from launch (Dec 2010)

    Distribution

    Nationwide Distribution

    Quantity

    173,329 units total (21,812 units in US)