Events

Retiro De Equipo (Recall) de WATCHMAN® Left Atrial Appendage Closure Device with Delivery System and WATCHMAN® Access SystemAccess Sheath with Dilator

Según Republic of Lebanon Ministry of Public Health, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Lebanon que fue producido por Boston Scientific.

¿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

Device

WATCHMAN® Left Atrial Appendage Closure Device with Delivery System and WATCHMAN® Access SystemAc...

Manufacturer

Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • 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.”
  • Representante del fabricante
    Care 4 Health S.A.R.L/DIMA HEALTHCARE SA
  • Source
    RLMPH