BEUDAMED
    FDA Recall Terminated

    20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

    Recall: Z-1023-2013 · Initiated March 5, 2013

    Recall

    Recall Number
    Z-1023-2013
    Event Number
    64579
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    March 5, 2013
    Posted
    March 28, 2013
    Terminated
    October 17, 2013
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

    Reason

    Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.

    Action

    Biosense Webster sent an Urgent Field Notice Medical Device Letter dated March 5, 2013 to all affected customers. The letter identified the affected product, problem and the actions to be taken. Customers with questions are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Mon-Friday from 7amto 8pm EST.

    Distribution

    Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.

    Quantity

    54 units