Events

Retiro De Equipo (Recall) de Device Recall Maverick 2" Monorail PTCA 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 Boston Scientific 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
    48608
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2166-2008
  • Fecha de inicio del evento
    2005-11-01
  • Fecha de publicación del evento
    2008-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71721
  • 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
    Percutaneous Catheter - Product Code LOX
  • Causa
    Two lots may not be correctly labeled. specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
  • Acción
    Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned.

Device

Device Recall Maverick 2" Monorail PTCA Catheter
  • Modelo / Serial
    Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
  • Descripción del producto
    Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-1225 || Use before 2007-01 || UPN H7493892812250 || Sterilized with ethylene oxide gas || Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm || Made in Ireland Ballybrit Business Park, Galway, Ireland || REF 38928-2035 || Use before 2007-01 || UPN H7493892820350 || Sterilized with ethylene oxide gas || Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA