Device Recall AdaptivCRT (aCRT)

  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong, New Zealand, Switzerland, Chile, India, Norway, Thailand, Cyprus, Iran, Poland, Turkey, Denmark, Ireland, Portugal, United Arab Emirates, Dominican Republic, Italy, Reunion, United Kingdom.
  • Descripción del producto
    Amplia MRI" CRT -D SureScan", || Amplia MRI" Quad CRT -D SureScan", || Claria MRI" CRT -D SureScan", || Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 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