Events

Retiro De Equipo (Recall) de HEARTMATE II LVAS - IMPLANT KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por THORATEC CORPORATION.

¿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
    41574
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-03-04
  • 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
    Serious patient injuries or death has been associated with the process of changing from one pocket controller to another.

Device

HEARTMATE II LVAS - IMPLANT KIT
  • Modelo / Serial
    Model Catalog: 106015 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106015 (Lot serial: Contact Manufacturer); Model Catalog: 106015 (Lot serial: All serial numbers); Model Catalog: 106762 (Lot serial: Contact Manufacturer); Model Catalog: 106016 (Lot serial: All serial numbers); Model Catalog: 106762 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106016 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106762 (Lot serial: All serial numbers); Model Catalog: 106016 (Lot serial: Contact Manufacturer); Model Catalog: 106017 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106017 (Lot serial: Contact Manufacturer); Model Catalog: 106017 (Lot serial: All serial numbers)
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    HeartMate II LVAS Implant Kit with Sealed Grafts (NAm)
  • Manufacturer
    THORATEC CORPORATION

Manufacturer

THORATEC CORPORATION
  • Dirección del fabricante
    PLEASANTON
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC