BEUDAMED
    FDA Enforcement Class II Terminated

    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

    Recall: Z-0054-2018 · Reported November 8, 2017

    Enforcement

    Recall Number
    Z-0054-2018
    Event ID
    78129
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2017
    Initiation Date
    September 6, 2017
    Classification Date
    October 27, 2017
    Termination Date
    November 19, 2019
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S

    Reason

    Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand catheters. Alert 402 implies a "Map: magnetic distortion" when connected to CARTO 3 System. This issue may subsequently lead the physician to ablate in an unintended area when delivering RF energy.

    Code Info

    17682851L 17682730L 17685880L 17685740L 17685692L 17680131L 1768581 lL 17685897L 17685789L 17676998L 17685889L 17685896L 17685792L 17685741L 17685758L 17685846L 17689428L 17689420L 17685881L 17680081L 17689454L 17682788L 17685853L 17685750L 17692068L 17689430L 17680080L 17682787L 17692069L 17689463L 17689421L 17685691L

    Distribution

    US, Japan, Canada, Australia, New Zealand, Brazil, Croatia, Korea, Austria, Colombia, Italy, Portugal, Argentina, South Africa, Belgium, France, Germany, Ireland, Poland, Netherlands, Sweden, Denmark, Finland, Switzerland, Great Britain, Hungary, Czech Republic, China

    Quantity

    357 units