BEUDAMED
    FDA Enforcement Class II Terminated

    LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

    Recall: Z-2153-2013 · Reported September 11, 2013

    Enforcement

    Recall Number
    Z-2153-2013
    Event ID
    65485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Genzyme Corporation, A Sanofi Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2013
    Initiation Date
    June 21, 2013
    Classification Date
    September 3, 2013
    Termination Date
    August 7, 2014
    Address
    175F New Boston St, N/A, Woburn, MA, 01801-6203, United States

    Description

    LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

    Reason

    Product contains particulates (fibers)

    Code Info

    All lot codes

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

    Quantity

    37 units