BEUDAMED
    FDA Recall Terminated

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    Recall: Z-1525-2015 · Initiated April 17, 2015

    Recall

    Recall Number
    Z-1525-2015
    Event Number
    71021
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    April 17, 2015
    Posted
    April 27, 2015
    Terminated
    December 10, 2015
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413

    Reason

    The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.

    Action

    A recall letter dated 4/17/15 will be sent to customers by FedEx to inform them that Biosense Webster is recalling Webster HIS catheter, 4Pole Fixed Curve with Auto ID (Catalog No. D1085413). The letter informs the customers of the problems identified and the actions to be taken. Customers with questions related to the recall letter are instructed to contact their Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the Voluntary Recall Certification Form and the process for returning the form, are instructed contact Elie Ghattas, Field Action Coordinator, at (909) 839-7281.

    Distribution

    US nationwide distribution.

    Quantity

    503 units