Device Recall Pipeline Embolization Device

  • Model / Serial
    Model/Lot Numbers:  FA-71400-25 / 9747602  FA-77350-18 / 9749412  FA-77400-20 / 9759088 FA-71500-35 / 9747604  FA-77375-16 / 9744487  FA-77425-16 / 9752788 FA-77300-16 / 9757068  FA-77375-20 / 9757065  FA-77425-20 / 9744123 FA-77325-14 / 9759141  FA-77400-14 / 9757233  FA-77425-20 / 9752438 FA-77325-16 / 9753034  FA-77400-14 / 9768698  FA-77450-18 / 9753033 FA-77325-16 / 9757024  FA-77400-16 / 9743468  FA-77475-20 / 9752787 FA-77325-18 / 9759560  FA-77400-18 / 9751579  FA-77500-20 / 9750678 FA-77350-16 / 9752785  FA-77400-20 / 9755707
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of AZ, KY, MO, NC, GA, WI, OR, FL, NY, CA, IL, TN, NV, TX, CO, MA, IA, UT and VA.
  • Product Description
    Pipeline Embolization Device (PED) || The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
  • 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