Events

Safety Alert for LEVEEN NEEDLE ELECTRODE. Anvisa Registry nº 10341350365. Lots Affected: Verify at http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_carta.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
    919
  • Date
    2008-05-12
  • 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 occurrence of an adverse event associated with the cited problem could lead to bleeding and soft tissue trauma due to the fact that the stems were not fully collected. Such an occurrence could lead to medical intervention. The letter of information to the clients and the form sent by Boston are in ANNEXES. Anvisa's Technovigilance Unit is monitoring this case. APPENDICES: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_carta.pdf http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_919_formulario.pdf UPDATE: The company communicated the closing the recall action and sending the products collected to the Boston Scientific Distribution Center located in Quincy / USA.
  • Reason
    Possibility of the leveen needle electrode cannula come out of its correct orientation inside the gauntlet, which can result in no full recoil of its rods.
  • Action
    Boston Scientific do Brasil Ltda has voluntarily initiated the market withdrawal of all unexpired batches of Agilha LeVenn SuperSlim Electrodes. The company has informed UTVIG that the distribution or use of any remaining product affected by this recall action of medical product must cease immediately. The instructions for health professionals are as follows: (1) Immediately discontinue use and segregate products affected by this recall; (2) Complete the verification / traceability form provided by the company and send the response to Boston Scientific do Brasil (fax 11-5502-8539, A / C Camila Domeneck); and (3) Pack and ship the product to the company, identifying the box with the customer's name (the company address is in the "Manufacturer's description" field of this form).

Device

LEVEEN NEEDLE ELECTRODE. Anvisa Registry nº 10341350365. Lots Affected: Verify at http://www.anvi...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA