HeartWare Ventricular Assist System

  • Modèle / numéro de série
    Serial #: ALL HeartWare HVAD systems currently in use.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, and VA; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
  • Description du dispositif
    HeartWare Ventricular Assist System (HVAD). || Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. || Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
  • Manufacturer
  • 3 Events

Fabricant

  • Adresse du fabricant
    HeartWare Inc, 14400 Nw 60th Ave, Miami Lakes FL 33014-2807
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    USFDA

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  • Modèle / numéro de série
  • Description du dispositif
    aimd
  • Manufacturer
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