Events

Retiro De Equipo (Recall) de GALEO PRO

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BIOTRONIK 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
    23403
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-11-14
  • 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
    The recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (ptfe) coating on parts of these devices.

Device

GALEO PRO
  • Modelo / Serial
    Model Catalog: 389791 (Lot serial: >100 numbers contact mfg); Model Catalog: 389788 (Lot serial: >100 numbers contact mfg); Model Catalog: 389787 (Lot serial: >100 numbers contact mfg); Model Catalog: 389786 (Lot serial: >100 numbers contact mfg); Model Catalog: 389785 (Lot serial: >100 numbers contact mfg); Model Catalog: 389784 (Lot serial: >100 numbers contact mfg); Model Catalog: 389783 (Lot serial: >100 numbers contact mfg); Model Catalog: 389782 (Lot serial: >100 numbers contact mfg); Model Catalog: 389781 (Lot serial: >100 numbers contact mfg)
  • Descripción del producto
    GALEO PRO CORONARY GUIDEWIRE
  • Manufacturer
    BIOTRONIK CANADA INC

Manufacturer

BIOTRONIK CANADA INC
  • Dirección del fabricante
    TORONTO
  • Empresa matriz del fabricante (2017)
    Ms Holding Ii Se
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    HC