BEUDAMED
    FDA Recall 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 · Initiated June 19, 2013

    Recall

    Recall Number
    Z-1617-2013
    Event Number
    65506
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    June 19, 2013
    Posted
    June 28, 2013
    Terminated
    February 7, 2014
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    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.

    Action

    An Urgent Field Notice letter was sent to all their customers who purchased the 20-Pole LASSO NAV Catheter Eco. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to complete and return the attached Voluntary Field Removal Certification Form in accordance with the instructions listed on the form. Customers are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday-Friday from 7:00AM to 8:00 PM EST if they have any questions. For questions related to the Voluntary Field Removal Certification Form and its return, customers are instructed to contact the Field Action Coordinator, at (909) 839-8468.

    Distribution

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

    Quantity

    10 units