Device Recall FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 7.0 mm

  • Modelo / Serial
    US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
  • Descripción del producto
    FIBERNET Embolic Protection System: || Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: || 0.014 in (0.36mm) || Rx only, Sterile; || Manufactured in: || Invatec S.P.A., Italy; || Manufacturer: || Medtronic Inc. || Minneapolis, MN. || The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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