Events

Safety Alert for CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See attachment at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/995_lista_produtos.pdf

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
    995
  • Date
    2009-11-03
  • 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
    Any distribution or use of any remaining product affected by this Voluntary Settlement must stop immediately. This Voluntary Collection does not include any product other than those of the affected lots listed in the Annex. Regulatory authorities around the world that are affected by this Voluntary Removal for Removal are being notified as required. Please carefully read the pickup instructions included with this Voluntary Referral Notification to the Customer. Your local Sales Representative can answer any questions you may have regarding this Volunteer Recruitment. More attachments at: http://www.anvisa.gov.br/tecnovigilancia/alertas/index.htm
  • Reason
    Boston scientific has concluded that the seal on the sterile packaging of the affected products may be compromised. it has been reported that the sealing of the outer pouch may be ruptured. if a compromised seal is not detected and a compromised sterile catheter is used in medical procedures, there is a risk of adverse health consequences, including bacteremia or infection and, in more extreme cases, sepsis, endocarditis, organ failure, and death.
  • Action
    The necessary actions are as follows: (1) Check in your stock if you have affected products; (2) Segregate affected products by visually identifying them with a label; (3) Contact the product registration holder (Boston Scientific of Brazil) or an authorized distributor for the return of the material. The use of affected products in stock must cease immediately.

Device

CATETER BALAO EQUALIZER - Registered at Anvisa under the number 10341350413. Model / Lot: See att...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA