Events

Safety Alert for LEVEEN NEEDLE ELECTRODE - ANVISA Register: 10341350365. Models: M001262160 and M001262160 - Lots (see annex).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific 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
    970
  • Date
    2009-07-20
  • 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
    See attachments.
  • Reason
    During a procedure, the umbrella - ventricular end - of the agualha leveen electrodes - 5.0 cm, can be released from the central wire, causing bleeding or slight tissue trauma, which may require intervention.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediate discontinuation of use and segregation of the affected product set forth in this notice; (2) Completely complete and return the Verification and Traceability Response Form to: Boston Scientific do Brasil - a / c Caroline Yin - Phone: (11) 5502-8510 or e-mail: yinv@bsci.com.

Device

LEVEEN NEEDLE ELECTRODE - ANVISA Register: 10341350365. Models: M001262160 and M001262160 - Lots ...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA