Events

Retiro De Equipo (Recall) de Device Recall Concentric 7F Balloon Guide Catheter

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
    51401
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0899-2011
  • Fecha de inicio del evento
    2009-02-27
  • Fecha de publicación del evento
    2011-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80199
  • 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, ventricular, general &, pastic surgery - Product Code GBS
  • Causa
    Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
  • Acción
    Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and identify any affected product. Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices. For questions regarding this recall call 877-471-0076.

Device

Device Recall Concentric 7F Balloon Guide Catheter
  • Modelo / Serial
    Lot numbers 33367 and 33407
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
  • Descripción del producto
    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
  • 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