Events

Retiro De Equipo (Recall) de Device Recall Strata II / Strata NSC valves

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Neurosurgery.

¿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
    76249
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1121-2017
  • Fecha de inicio del evento
    2017-01-17
  • Fecha de publicación del evento
    2017-02-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152582
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery initiated a recall after receiving five (5) product experiences between february 15, 2015 and august 23, 2016 reporting of discrepancies between the pressure/performance level (pl) at which the valve was set and the readings determined via an x-ray image.
  • Acción
    Medtronic sent an Urgent Product Advisory Notice dated January 19, 2017, was sent to customers to inform them that Medtronic Neurosurgery is initiating a voluntary field corrective action (FCA) for the Medtronic Strata II / Strata NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR). Medtronic is notifying healthcare providers of an Instructions For Use (IFU) Warning update for the affected products by sending a Product Advisory Notice. For further questions regarding this recall please call (805) 571-8400..

Device

Device Recall Strata II / Strata NSC valves
  • Modelo / Serial
    All Lot Numbers
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria
  • Descripción del producto
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. || Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. || Strata Valve Magnet Reverse Polarity (Excludes StrataMR). || Catalog No. || 27739 || 27740 || 27786 || 27787 || 27788 || 27789 || 27794 || 27812 || 27814 || 27815 || 27816 || 27817 || 27818 || 27820 || 27821 || 27822 || 27823 || 27824 || 27825 || 27827 || 27828 || 27830 || 27831 || 27832 || 27848 || 27864 || 27867 || 27868 || 27888 || 27903 || 27922 || 27823 || 27924 || 23042 || 27925 || 27926 || 27927 || 27932 || 27933 || 42335 || 42355 || 42365 || 42836 || 42856 || 42866 || 44420 || 44421 || 44430 || 44465 || 46070 || 46075 || 46080 || 46085 || 46635 || 46655 || 46665 || 46836 || 46856 || 46866 || 46871 || 46876 || 46881 || 46886 || 92355 || 92365 || 92856 || 92866 || 96655 || 96665
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Dirección del fabricante
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • 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
    USFDA