Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device

  • Model / Serial
    All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    MindFrame Capture LP Revascularization Devices: Product Numbers: || (a) REF 300010 || (b) REF 300011 || (c) REF 300012 || (d) REF 300013 || (e) REF 300014 || (f) REF 300015 || (g) REF 300016 || (h) REF 300017 || (i) REF 300018 || Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
  • 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