Retiro De Equipo (Recall) de AngioJet Ultra 5000A Console - Foot Switch

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific Pty 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
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    There have been reports regarding the angiojet ultra 5000a console foot switch sticking during use resulting in an undesired continued operation of the device. this situation can occur as a result of the wear and tear of the foot switch, which is normally captured through routine servicing. the most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. at this stage, there have been no reported patient adverse events as a result of these complaints.
  • Acción
    Users are advised that if the situation occurs during use, perform the troubleshooting steps per the operator’s manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. Boston Scientific is advising users who have this issue to discontinue use of the AngioJet Ultra 5000A Console foot switch and to contact their local sales representative. No action is required by users whose device is operating correctly.



  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source