BEUDAMED
    FDA Recall 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 · Initiated January 28, 2013

    Recall

    Recall Number
    Z-0928-2013
    Event Number
    64344
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    MRM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 28, 2013
    Posted
    March 8, 2013
    Terminated
    December 9, 2015
    Address
    14401 W 65th Way, Arvada, CO, 80004

    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.

    Action

    Sorin C.R.M., srl sent an Urgent Medical Device Field Safety Notice dated January28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return any unused products by certified mail with signed acknowledgment form, patients should continue to be monitored by their physician field reps during notification visit, and customers should make sure all personnel involved in the management of patients implanted with affected product are aware of the information described in the Field Safety Notice. Customers with questions should contact their local Sorin representative at 1-610-304-9728. For questions regarding this recall call 303-467-6222.

    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