Alligator Retrieval Device (ARD)

  • Model / Serial
    ARD Model/ Lot  FA8881040 / 9769118  FA8881030 / 9816048 FA8881040 / 9754682  FA8881050 / 9772283  FA8881040 / 9752800 FA8881030 / 9751662  FA8881030 / 9773525  FA8881020 / 9832735 FA8881040 / 9757667  FA8881020 / 9774620  FA8881030 / 9834039 FA8881040 / 9758530  FA8881020 / 9774620  FA8881030 / 9834039 FA8881030 / 9758532  FA8881030 / 9783730  FA8881020 / 9836553 FA8881050 / 9760946  FA8881040 / 9786013  FA8881030 / 9834039 FA8881030 / 9761690  FA8881040 / 9787928  FA8881050 / 9848544 FA8881020 / 9761692  FA8881030 / 9791385  FA8881030 / 9848543 FA8881030 / 9758532  FA8881040 / 9793305  FA8881030 / 9853152 FA8881040 / 9764206  FA8881030 / 9798648  FA8881030 / 9854769 FA8881040 / 9764206  FA8881030 / 9798648  FA8881030 / 9858153 FA8881040 / 9764212  FA8881050 / 9801041  FA8881030 / 9865759 FA8881030 / 9766949  FA8881020 / 9811215  FA8881050 / 9868025 FA8881030 / 9769117  FA8881030 / 9813908
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
  • Product Description
    Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
  • 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