Events

Retiro De Equipo (Recall) de Guidant CONTAK RENEWAL 3 RF & 4 RF

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 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
    36495
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0269-2007
  • Fecha de publicación del evento
    2006-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-04-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48748
  • 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
    Defibrillator - Product Code LWP
  • Causa
    Shock effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. while no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
  • Acción
    An Important Medical Device Information letter, dated 10/09/2006 was sent to physicians following patients with a potentially affected device. The letter describes the issue, provides for a projected rate of occurrence, and provides recommendations. An October 9, 2006 Product Advisory Letter, beginning October 30, 2006, was also sent to provide an update that further laboratory testing and analysis indicates that the nominal probability of malfunction is higher than their earlier prediction. Non-implanted devices have been retrieved.

Device

Guidant CONTAK RENEWAL 3 RF & 4 RF
  • Modelo / Serial
    Model H210, serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525.   Model H215, serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425.   Model H217, serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350.   Model H219, serial numbers: 203320, 203344, 203355, 203377, 203382.   Model H230, serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155.   Model H239, serial numbers: 650451, 650453, 650454.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution ---- including states of CA, FL, GA, IA, IL, KY, MA, MO, NJ, NY, OH, PA, TX and countries of Italy, Netherlands, Sweden, United Kingdom.
  • Descripción del producto
    Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Dirección del fabricante
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA