BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.

    Recall: Z-2147-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2147-2014
    Event ID
    68700
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific CRM Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    June 19, 2014
    Classification Date
    August 4, 2014
    Termination Date
    December 3, 2014
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems.

    Reason

    A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.

    Code Info

    Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339.

    Distribution

    Worldwide Distribution -US (nationwide) in the states of OH, MN and country of France

    Quantity

    21