Events

Retiro De Equipo (Recall) de Device Recall Ev3, Inc. (Medtronic)

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 ev3, Inc..

¿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
    73706
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1552-2016
  • Fecha de inicio del evento
    2016-03-29
  • Fecha de publicación del evento
    2016-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144786
  • 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
    Catheter, angioplasty, peripheral, transluminal - Product Code LIT
  • Causa
    Medtronic is conducting a voluntary urgent medical device recall of two lots of the powercross 0.018" ¿ over the wire (otw) percutaneous transluminal angioplasty (pta) dilatation catheter because the product is mislabeled.
  • Acción
    Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.

Device

Device Recall Ev3, Inc. (Medtronic)
  • Modelo / Serial
    A213373 and A216702
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
  • Descripción del producto
    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
  • Manufacturer
    ev3, Inc.

Manufacturer

ev3, Inc.
  • Dirección del fabricante
    ev3, Inc., 3033 Campus Drive, Minneapolis MN 55441
  • 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