Events

Retiro De Equipo (Recall) de Device Recall Taxus

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 Boston Scientific Scimed.

¿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
    29479
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1052-04
  • Fecha de inicio del evento
    2004-07-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34107
  • 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
    Coronary Drug-Eluting Stent - Product Code NIQ
  • Causa
    On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
  • Acción
    July 2 and 16, 2004 recall letters were sent to user accounts, such as Hospitals and clinics of the need to recall TAXUS Express2 Paclitaxel-Eluting and Express 2 Coronary Stent Systems. Recall was due to characteristics in the delivery catheters that had the potential to impede balloon deflation during a coronary angioplasty procedure, a condition known as focal neckdown. An additional 38 lots were added to the recall on August 5, 2004, for the same reason.

Device

Device Recall Taxus
  • Modelo / Serial
    No 2.25 mm lots were distributed in U.S. U.S Distributed - 2.5 mm - Lot number/Exp. Date: 6171851 May-04 U.S Distributed - 2.75 mm - Lot number/Exp. Date: 6294706 Jun-04 U.S Distributed - 3.0 mm - Lot number/Exp. Date: 6337153 Jul-04 6422009 Aug-04 6555155 Sep-04 6271481 Jun-04 U.S Distributed - 3.5mm - Lot number/Exp. Date: 6111269 Apr-04 No 4.0 mm lots distributed in U.S. No TAXUS OTW were sold outside the U.S.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Canada
  • Descripción del producto
    TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm).
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

Boston Scientific Scimed
  • Dirección del fabricante
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA