Events

Retiro De Equipo (Recall) de Peripheral stent Pulsar-18 with delivery system

Según Federal Service for Surveillance in Healthcare, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Russian Federation que fue producido por BIOTRONIK AG.

¿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
    01И-1129/15, ФСЗ 2011/10641
  • Fecha
    2015-07-10
  • Fecha de publicación del evento
    2015-07-22
  • País del evento
    Russian Federation
  • Fuente del evento
    FSSH
  • URL de la fuente del evento
    http://www.roszdravnadzor.ru/services/unreg
  • Notas / Alertas
    Russian data is current through January 2019. All of the data comes from the Federal Service for Surveillance in Healthcare, 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 Russia.
  • Notas adicionales en la data
    Manufacturer Recall

Device

Peripheral stent Pulsar-18 with delivery system

Manufacturer

BIOTRONIK AG
  • 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
    FSSH