Events

Retiro De Equipo (Recall) de Device Recall VOYAGER NC Coronary Dilatation 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 Abbott Vascular-Cardiac Therapies dba Guidant Corporation.

¿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
    50192
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0938-2009
  • Fecha de inicio del evento
    2008-11-05
  • Fecha de publicación del evento
    2009-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74927
  • 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
    Stent, coronary - Product Code MAF
  • Causa
    The recall was initiated after abbott vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter voyager nc coronary dilatation catheter has been tight. if unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. the balloon sheath covers the balloon, maintaining the fold configuration and protects the.
  • Acción
    An Urgent Device Recall letter (dated November 6, 2008) with an Efficacy Check Reconciliation form was issued and hand-carried to affected customers by their respective Sales Representative who assisted in locating and returning the recalled units. The letter described the problem and informed customers that Abbott Vascular will replace returned recalled product with like product or with VOYAGER NC sizes when they become available. Additionally, customers were instructed to contact their Abbott Vascular local account representative to review their inventory, complete and return the attached Efficacy Check Reconciliation Form and return affected products to Abbott Vascular.

Device

Device Recall VOYAGER NC Coronary Dilatation Catheter
  • Modelo / Serial
    Part Number: 1011759-08, Lot Numbers: 8050961 and 8062361.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. || The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.
  • Manufacturer
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Manufacturer

Abbott Vascular-Cardiac Therapies dba Guidant Corporation
  • Dirección del fabricante
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation, 26531 Ynez Rd, Temecula CA 92591-4630
  • Source
    USFDA