Events

Retiro De Equipo (Recall) de HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HEARTWARE 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
    74044
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-05-10
  • 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
    Heartware recall: the exact cause of the event cannot be conclusively determined.

Device

HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER
  • Modelo / Serial
    Model Catalog: 1401XX (Lot serial: >10 numbers contact mfg); Model Catalog: 1407XX (Lot serial: >10 numbers contact mfg); Model Catalog: 1400 (Lot serial: >10 numbers contact mfg); Model Catalog: 1408 (Lot serial: >10 numbers contact mfg)
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    HeartWare Controller
  • Manufacturer
    HEARTWARE INC.

Manufacturer

HEARTWARE INC.
  • Dirección del fabricante
    MIAMI LAKES
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC