Events

Safety Alert for Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 145-5091-150; 190-5091-150; 105-5092-150; 5092-150

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE DO BRASIL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1393
  • Date
    2014-06-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    According to the company, due to the incorporation of EV3 Comércio de Produtos by Auto Suture do Brasil, it will continue with all actions related to this field action, EV3 of Endovascular Products being the holder of this register. ### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • Reason
    "during the update of the nationalization label of the product in question, the registration number (80102510081) of the holder vr medical imp. and dist. prod. medicos ltda. , to 80301610021, registered by ev3 endovascular products trading of brasil ltda. however, this modification contemplated only the registration number and remained with obsolete registration holder information. " the company also reported that it did not identify risk to the patient and reported that the problem does not interfere with the use of the product.
  • Action
    It will be corrected in the Nationalization Tag Update field. ## According to the company (Field Action notification form), the products under risk in Brazil are quantified as follows: Total product under risk in Brazil: 795; Marketed quantity: 466; Quantity in stock: 329.

Device

Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 1...

Manufacturer

Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE DO BRASIL LTDA
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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
    ANVSANVISA