BEUDAMED
    FDA Enforcement Class II Terminated

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    Recall: Z-0058-2018 · Reported November 8, 2017

    Enforcement

    Recall Number
    Z-0058-2018
    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 SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-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

    17637495L 17638389L 17639706L 17639707L 17639708L 17640039L 17640494L 17640952L 17640040L 17640742L 17640953L 17640041L 17640743L 17640954L 17640490L 17640744L 17643130L 17638118L 17638387L 17638388L

    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

    329 units