Events

Retiro De Equipo (Recall) de Device Recall Stryker brand Neuroform 3 Microdelivery Stent System

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 Stryker Neurovascular.

¿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
    65654
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1808-2013
  • Fecha de inicio del evento
    2013-06-24
  • Fecha de publicación del evento
    2013-07-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119819
  • 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
    intracranial neurovascular stent - Product Code NJE
  • Causa
    The device is labeled incorrectly, in that, the device model number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. the model number on the outer box states upn m003e345020 (4.5mm x 20 mm neuroform 3 stent) while the pouch label states upn m003e3450300 (4.5mm x 30 mm neuroform 3 stent).
  • Acción
    Stryker Neurovascular sent an Urgent Field Safety Notice on June 28, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their internal inventory and quarantine all subject devices pending return to Stryker. Circulate the Field Safety Notice internally to all interested/affected parties. Maintain awareness of this notice internally until all requred actions have been completed within their facility. Inform Stryker if any of the subject devices were distributed to other organization. Complete the attached customer response form and return to their Stryker Representataive. For questions regarding this recall call 510-413-2500.

Device

Device Recall Stryker brand Neuroform 3 Microdelivery Stent System
  • Modelo / Serial
    Code: M003450200, Lot 15391019, Expiration Date: 2015-07
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    HDE
  • ¿Implante?
    Yes
  • Distribución
    International Distribution including Austria, China, and Germany.
  • Descripción del producto
    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA || The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Dirección del fabricante
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA