FIBERNET® Embolic Protection System.

  • Model / Serial
    Model Number: FBC350500190, Lot number: 1E029174 Model Number: FBC500600190, Lot number: 1E029176 Model Number: FBC600700190, Lot number: 1E029750 Model Number: FBN350500190, Lot number:1E012912 Model Number: FBN500600190, Lot number:1E012914 Model # FBN600700190, Lot # 1E012916 and 1E017817
  • Product Description
    A matrix of specially shaped PET-fibers to effectively capture arterial micro-emboli
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Manufacturers representative
    Alhaya medical co., Riyadh, (011) 465 5075
  • Source
    SFDA