Events

Retiro De Equipo (Recall) de Medtronic Intersept

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 Medtronic Perfusion Systems.

¿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
    37273
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1110-2007
  • Fecha de inicio del evento
    2007-04-18
  • Fecha de publicación del evento
    2007-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50236
  • 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
    Cardiotomy Reservoir - Product Code DTZ
  • Causa
    Pyrogen levels detected above specification: the product contains a pyrogen level above medtronic''s internal specifications while the product is labeled as nonpyrogenic.
  • Acción
    The consignees were notified by personal contact and requested to stop using the devices in question. A customer letter (April 24, 2007) will be sent by e-mail which explains the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a Recall Certificate acknowledging the receipt of this information.

Device

Medtronic Intersept
  • Modelo / Serial
    Lot 7192800
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide: Distributed to states of CO and PA
  • Descripción del producto
    Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • Dirección del fabricante
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA