Events

Safety Alert for Vent Edwards cannula. Models at risk: E060, E061, PE062. Anvisa Registry n ° 80219050029.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Edwards Lifescience Comércio de Produtos Ltda.; Edwards Lifesciences LLC.

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
    1473
  • Date
    2014-12-01
  • 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
    Check carefully the information of the Alert Message disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/9ac0e100467186e6bb4abf99223cd76e/Message+of+Alerta+1473.pdf?MOD=AJPERES.
  • Reason
    The product may release fragments of material (white plastic) during insertion, which may migrate into the patient's vasculature and eventually reach the patient's ventricle, potentially causing neurological or cardiac embolism or injury.
  • Action
    Field correction. Check carefully the information of the Alert Message disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/9ac0e100467186e6bb4abf99223cd76e/Messagem+de+Alerta+1473.pdf?MOD=AJPERES

Device

Vent Edwards cannula. Models at risk: E060, E061, PE062. Anvisa Registry n ° 80219050029.

Manufacturer

Edwards Lifescience Comércio de Produtos Ltda.; Edwards Lifesciences LLC