Retiro De Equipo (Recall) de Device Recall CONTAK RENEWAL AVT CRTD

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 CRM Corp.

¿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
    32738
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1109-05
  • Fecha de inicio del evento
    2005-07-25
  • Fecha de publicación del evento
    2005-08-16
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
  • Causa
    Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.
  • Acción
    Urgent Medical Device Safety Information & Corrective Action letter dated 07/22/05 was either mailed or Federal Expressed to doctors. This letter informed doctors that Guidant was revising its original recommendations set forth in the June 17, 2005 letter because new information indicates that one of the original recommendations can increase the risk of a latching event. Contained in this letter were Clinical Implications and Revised Recommendations.

Device

  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide. In addition to the US other countries include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.
  • Descripción del producto
    CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK RENEWAL 3 AVT HE model numbers M157 and M159; CONTAK RENEWAL 4 AVT, model numbers M170 and M175; CONTAK RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798, USA. CONTAK RENEWAL AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA