Events

Safety Alert for GORE INTERING Vascular Graft; Record: 80067930023 /// GORE ACUSEAL Cardiovascular Patch; Record: 80067930009 /// GORE-TEX Strech Vascular Graft; Registration: 80067930024 /// GORE PRECLUDE Dura Substitute; Registry: 80067930016. Class of risk: IV. Serial Number: AT ANNEX.

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
    1558
  • Date
    2015-03-26
  • 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
    The company filed a request to change the registry.
  • Reason
    Discrepancy between the sterilization certificate and the sterilization method reported in the registry.
  • Action
    The company holding the registration forwarded a notice to all distributors of the product informing them not to release new import orders until the modifications in the registration are approved and published by Anvisa and quarantine the products in order not to distribute and market the stocks.

Device

GORE INTERING Vascular Graft; Record: 80067930023 /// GORE ACUSEAL Cardiovascular Patch; Record: ...

Manufacturer

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