Device Recall Axium Detachable Coil System QC21Helix

  • Model / Serial
    Lot # 7964576
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of the UK, and France.
  • Product Description
    Axium Detachable Coil System QC-2-1-Helix || The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae.
  • 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