Retiro De Equipo (Recall) de Abbott Hi-Torque Connect Peripheral Guide Wire

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Lake Region Medical Ltd.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Vascular Division of Abbott Laboratories (NZ) Ltd, Ground Floor, Building D, 4 Pacific Rise, Mount Wellington, Auckland 1060
  • Causa
    Abbott vascular has initiated this recall due to a small number of devices exhibiting partial delamination of the ptfe coating. to date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%. while there have been no long term or irreversible patient effects reported, potential risks associated with delamination of the coating include embolism, thrombus and occlusion in the peripheral vessels.
  • Acción
    Product to be returned to supplier


  • Modelo / Serial
    Model: Part Numbers: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595, Affected: All lot numbers
  • Manufacturer