Device Recall Implantable Defibrillation Lead

  • Modèle / numéro de série
    Models: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • 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.
  • Description du dispositif
    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
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Société-mère du fabricant (2017)
  • Source
    USFDA