BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.

    Recall: Z-1456-05 · Initiated July 15, 2005

    Recall

    Recall Number
    Z-1456-05
    Event Number
    32764
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2005
    Posted
    August 31, 2005
    Terminated
    February 7, 2007
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.

    Reason

    The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors.

    Action

    Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand.

    Distribution

    Nationwide, Germany, Italy, Netherlands, Spain and Sweden.

    Quantity

    115