Events

Retiro De Equipo (Recall) de Device Recall Merci Retriever

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 Concentric Medical 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
    69119
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2598-2014
  • Fecha de inicio del evento
    2014-06-25
  • Fecha de publicación del evento
    2014-09-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129669
  • 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
    Catheter, thrombus retriever - Product Code NRY
  • Causa
    Merci retrievers were shipped to us customers past their expiration date, even though they were labeled with the correct expiration date.
  • Acción
    Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.

Device

Device Recall Merci Retriever
  • Modelo / Serial
    Model Number 90109; Lot number 35695
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of PA, CA, TX, NM, and OH.
  • Descripción del producto
    Merci Retriever || Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Dirección del fabricante
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA