Device Recall LeGoo Endovascular Occlusion Gel 1.0 mL LeGoo w/ no Cannula

  • Modèle / numéro de série
    All lot codes
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula || Product Number: PV-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

Fabricant

  • Adresse du fabricant
    Genzyme Corporation, A Sanofi Company, 175F New Boston St, Woburn MA 01801-6203
  • Société-mère du fabricant (2017)
  • Source
    USFDA