Device Recall EnTrust AT ICD

  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Descripción del producto
    Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source