Device Recall CONTAK RENEWAL AVT CRTD

  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide. In addition to the US other countries include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
  • Description du dispositif
    CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA