Events

Alerta De Seguridad para Reusable Handles with Sharp Tips Used with the Medtronic AneuRx Stent-Graft System (Tapered-Tip Reusable Handles used with Medtronic AneuRx Stent-Graft Systems Catalog Nos .: (1) YRBR2012135, (2) YRBR2012165, (3) YRBR2213135, (4) YRBR2213165, (5) YRBR2414135, (6) YRBR2414165, (7) YRBR2615135, (8) YRBR2615165, (9) YRBR2816135, (10) YRBR2816165, (11) YRBR3116135, (12) YRBR3116165, (1) PD03138-20, (2) PD03139-20, (15) YREC22375, (16) YREC24375, (17) YREC26375, (18) YREC28375, (19) YREC31375, (3) PD03138-22, (4) PD03139-22, (5) PD03138-24, (6) PD03139-24, (7) PD03138-26, (8) PD03139-26, (9) PD03138-28, 10) PD03139-28, (11 to 13, 19) Unidentified, (14) PD03140-20, (15) PD03140-22, (16) PD03140-24, (17) PD03140-26, (18) PD03140-28 )

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Medtronic 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
    649
  • Fecha
    2000-06-13
  • 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
    01/30/2002 - The company informs that STENT VASCULAR PERIFERICO VASCUCOIL was not imported by Medtronic Comercial Ltda, or by any other authorized distributor, and consequently there is no unit of this product in Brazil.
  • Causa
    The aforementioned sharp-tip reusable handles can be detached from the stent-graft catheter system. the distributor initiated a mailing removal dated june 13, 2000.
  • Acción
    Make sure that you have received the June 13, 2000 correspondence from Medtronic AVE. Identify and collect any affected product from your inventory. For product return information, please contact your Medtronic AVE representative or mail to the address listed above.

Device

Reusable Handles with Sharp Tips Used with the Medtronic AneuRx Stent-Graft System (Tapered-Tip R...

Manufacturer

Medtronic Inc
  • Source
    ANVSANVISA