Device Recall The AXIUM DETACHABLE COIL SYSTEM

  • Model / Serial
    Lot Number: 5871057
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of CA, CT, NE, NV, and WI. and the countries of Argentina, Brazil, Colombia, and Egypt.
  • Product Description
    Axium Detachable Coil System Model Number: QC-2-2-3D. || The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Micro Therapeutics Inc, dba ev3 Neurovascular, 9775 Toledo Way, Irvine CA 92618-1811
  • 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.
  • Source
    USFDA