Events

Retiro De Equipo (Recall) de Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.

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
    75813
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0938-2017
  • Fecha de inicio del evento
    2016-11-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151371
  • 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 is conducting a recall on boston scientific ingevity" mri endocardial pacing leads. there is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.
  • Acción
    Boston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000.

Device

Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.
  • Modelo / Serial
    Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
  • Descripción del producto
    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA