Events

Safety Alert for VENOSA CANAL SARNS. Model: VENOUS CRANE MVD DOUBLE CROSS STAGE 4934; 4935; 4936. Anvisa Registry n ° 80012280011.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Terumo Cardiovascular System Corporation; Terumo Medical 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
    1372
  • Date
    2014-03-27
  • 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
    Verify additional information with Terumo Medical do Brasil Ltda - Tel.:(11) 3594-3845 / FAX: (11) 3594-3802 / e-mail: ra@terumo.com.br.
  • Reason
    Exposure of metal wire that gives "memory" to the cannula. exposed metal wire is usually detected prior to the procedure but, if not detected, its use may result in damage to cardiac tissue and a remote chance of air introduction into the cardiopulmonary bypass.
  • Action
    The registration holder is collecting the product in Brazil. If you own this product in your establishment, segregate it and contact the manufacturer / authorized dealer.

Device

VENOSA CANAL SARNS. Model: VENOUS CRANE MVD DOUBLE CROSS STAGE 4934; 4935; 4936. Anvisa Registry ...

Manufacturer

Terumo Cardiovascular System Corporation; Terumo Medical do Brasil Ltda.