Events

Retiro De Equipo (Recall) de ATLAS GOLD PTA DILATATION CATHETER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BARD CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    22287
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    To inform customers that specific product code / lot number combinations may be at risk of having a balloon wall thickness that is higher than the required specification which could result in a slight increase in the force required to advance the balloon through the sheath and/or withdraw the balloon after inflation and deflation and could potentially lead to a slight prolongation of the procedure. potentially there may also be an increase in the balloon's non-compliance and rigidity. product return is not required.

Device

ATLAS GOLD PTA DILATATION CATHETER
  • Modelo / Serial
    Model Catalog: ATG120182 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120162 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120244 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80164 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG80222 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: ATG120184 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Descripción del producto
    ATLAS GOLD PTA DILATATION CATHETER
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.