Device Recall Medtronic Advanced Energy Aquamantys3 Pump Generator

  • Modelo / Serial
    lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
  • Descripción del producto
    Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) || The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Advanced Energy, LLC, 180 International Dr, Portsmouth NH 03801-6837
  • 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