BEUDAMED
    FDA Enforcement Class II Terminated

    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias

    Recall: Z-0928-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0928-2013
    Event ID
    64344
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    January 28, 2013
    Classification Date
    March 8, 2013
    Termination Date
    December 9, 2015
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004, United States

    Description

    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias

    Reason

    Isoline defibrillation leads distributed may have internal insulation breach.

    Code Info

    Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13

    Distribution

    Worldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.

    Quantity

    1376 Isoline leads