Events

Retiro De Equipo (Recall) de Device Recall CONFIENT Implantable Cardioverter Defibrillator

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
    55216
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1555-2010
  • Fecha de inicio del evento
    2010-03-15
  • Fecha de publicación del evento
    2010-05-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90348
  • 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
    Boston scientific corporation has stopped shipment and is retrieving unimplanted devices from us hospital shelves of all its implantable cardioverter defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) after determining that some manufacturing process changes were not submitted for approval to the us food & drug administration.
  • Acción
    BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers. For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).

Device

Device Recall CONFIENT Implantable Cardioverter Defibrillator
  • Modelo / Serial
    Model E030, serial numbers: 504800, 505054, 505073, 506067, 506886, 506961, 507219, 507236, 507255, 507268, 507292, 507304, 507332, 507372, 507381, 507388, 507412, 507424, 507446, 507448, 507449, 507454, 507467, 507527, 507538, 507577, 507594, 507600, 507607, 507614, 507618, 507625, 507728, 507742, 507757, 507785, 507829, 507840, 507882, 507898, 507903, 507904, 507923, 507940, 507943, 507944, 507952, 507960, 507963, 507966, 507984, 508001, 508008, 508059, 508130.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    nationwide within US only (OUS distribution not affected).
  • Descripción del producto
    Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation(VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798. USA.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

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