Alerta De Seguridad para CATEGORIE ANGIOGRÁFICO IMAGER II. Registro Anvisa n ° 10341350453. List of affected lots available at:

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Boston Scientific Corporation; Boston Scientific do Brasil Ltda.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to information presented by Boston Scientific, the holes are not detectable by visual inspection of the product. The problem has been investigated by the company and the most likely cause is that there has been physical interaction between the outer carton of the product and its internal packaging during transportation of the product. For other information and access to the Monitoring Form provided by the company, see the Letter of Notification to the client available in: #### 28/06/2012 - UPDATE - Completion of the field action, resulting in the collection of 1519 units, all exported to Boston Scientific Corporation - Quincy. ####
  • Causa
    Small holes in the package can cause loss of product sterility.
  • Acción
    To the user of the product the following actions are recommended: look for in your stocks products affected by this recall and, if you locate them, stop using them immediately. Segregate and identify the affected products to avoid inadvertent use. Fill out and return the Follow-up Form to Boston Scientific do Brasil Ltda, even if you do not have affected products in your stock - email and Fax: (11) 5853-2631. After sending the form, wait for company contact for shipping and replacement of products.


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source