Events

Safety Alert for Trade Name: GORE-TEX VASCULAR GRAFTS; registration: 80067930035; class of risk: IV ///// Trade Name: GORE INTERING VASCULAR RUBBER; registration: 80067930023; class of risk: IV ////// Trade Name: GORE HYBRID VASCULAR PROSTHETIC; registration: 80067930034; class of risk: IV ///// Trade Name: GORE-TEX STRETCH VASCULAR GRAFTS; registration: 80067930024; class of risk: IV ///////// Trade Name: GORE VIATORR TIPS ENDOPROTHESES; registration: 80067930029; class of risk: IV ///// Trade Name: GORE VIABAHN ENDOPROSTHESIS; registration: 80067930020; class of risk: IV

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by W.L. GORE & ASSOCIATES DO BRASIL LTDA.; W.L. Gore & Associates, Inc..

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
    1854
  • Date
    2016-04-12
  • 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
  • Reason
    The wl gore & associates do brasil ltda company that registered these products in october 2015 received good manufacturing practices inspection reports that had unsatisfactory results regarding 6 (six) wl gore inc plants in flagstaff. subsequently, said company received notification of the supervision of anvisa, no. 902/2015 of gfisc / ggfis / sucom / anvisa requesting the suspension of imports of all products manufactured in the 06 plants of flagstaff. 07 december 2015 was published in official gazette resolution re 3 366 of december 4, 2015 requesting the suspension of import, distribution and marketing of 07 products.
  • Action
    Gathering affected products. Action code 002/2015.

Device

Trade Name: GORE-TEX VASCULAR GRAFTS; registration: 80067930035; class of risk: IV ///// Trade Na...

Manufacturer

W.L. GORE & ASSOCIATES DO BRASIL LTDA.; W.L. Gore & Associates, Inc.