Device Recall CONTAK RENEWAL 4 and CONTAK RENEWAL 4 HE

  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    worldwide. Including United States, Virgin Islands and countries such as Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Canada, Cayman Islands, Chile, Colombia, Cyprus, Czech Republic, Denmark, Eygpt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Labanon, Luxembourg, Marshall Islands, Mexico, Netherlands, New Zealand, Northern Mariana Islands, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom and Venezuela.
  • Description du dispositif
    CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5511-5798 USA. CONTAK RENEWAL 4 devices provide ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA