Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch

  • Modelo / Serial
    All lot codes
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch || Product Number: CS-100 || 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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA