BEUDAMED
    FDA Recall Terminated

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    Recall: Z-2666-2011 · Initiated May 23, 2011

    Recall

    Recall Number
    Z-2666-2011
    Event Number
    58884
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DRF
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    May 23, 2011
    Posted
    June 27, 2011
    Terminated
    October 12, 2012
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.

    Reason

    The recall was initiated because Biosense Webster, Inc. has recently become aware that 20 electrodes catheters with Auto ID Technology are not being recognized when connected to the CARTO 3 System.

    Action

    Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore

    Quantity

    289 units (107 in US)