Events

Retiro De Equipo (Recall) de Device Recall Trevo Pro 4 Stent 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
    69799
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0528-2015
  • Fecha de inicio del evento
    2013-11-13
  • Fecha de publicación del evento
    2014-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131562
  • 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
    Product shipped to us customers had non u.S. instruction for use with indication for use that were not aligned with u.S. indications.
  • Acción
    The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 18, 2013 to all affected customers by traceable mail. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately locate the subject devices and quarantine them; distribute this notice to all affected departments in your facility; inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.

Device

Device Recall Trevo Pro 4 Stent Retriever
  • Modelo / Serial
    Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to states of: CA, IN, PA, AL, and NJ.
  • Descripción del producto
    Trevo Pro 4 Stent Retriever, || Model number 80021; || U.S. Indications for use: The Trevo Retriever is intended to restore blood || flow in the neurovasculature by removing thrombus in patients experiencing || ischemic stroke within 8 hours of symptom onset. Patients who are ineligible || for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA || therapy are candidates for treatment.
  • 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