Events

Alerta De Seguridad para Product name: Ultraflow / Marathon Flow Directed Catheter Catheter Technical Name: ANVISA Registration Number: 80102510439/80102510082 Hazard Class: Affected Model: Not applicable

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR Medical LTDA.; MICRO THERAPEUTICS, INC..

¿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
    2123
  • Fecha
    2016-12-05
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    In the case of affected products that have already been used, no action is necessary and patients should continue to be monitored in accordance with the patient's protocol of conduct. If the products affected by the recall have not been used, we request that the customer immediately take the following actions: 1. Remove and quarantine all unaffected products in inventory. 2. Return potentially affected products to Medtronic.
  • Causa
    Medtronic has identified a potential problem with a specific batch number group of medtronic neurovascular products, as noted below, where the ptfe (polytetrafluoroethylene) coating could delaminate and separate from the shaft. as a result, we will proceed with the withdrawal of the products from the market. this problem affects all batches of the following medtronic products that have an expiration date between june 2017 and august 2019: 1. marathon micro flow directed catheter (with mandrel) 2. ultraflow hpc flow oriented microcateter (with mandrel).
  • Acción
    Field Action Code AC03 triggered under the responsibility of the company VR Medical LTDA. Company will make collection for further export to Medtronic.

Device

Product name: Ultraflow / Marathon Flow Directed Catheter Catheter Technical Name: ANVISA Registr...

Manufacturer

VR Medical LTDA.; MICRO THERAPEUTICS, INC.
  • Source
    ANVSANVISA