Retiro De Equipo (Recall) de Device Recall 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 Medtronic CardioVascular.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Endovascular Stent - Product Code MIH
  • Causa
    Sterility compromised: device sterility may be compromised as evidenced by a loss of outer package integrity.
  • Acción
    Medtronic sent Urgent Communication - Medical Device Correction Advisory Notice letters to all its direct consignees on 12/7/07, via Federal Express, informing them of the affected product and providing instructions on avoiding contamination of the sterile surgical field with these devices.


  • Modelo / Serial
    All codes
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Medtronic brand AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System; || Model Numbers Affected: All AAAdvantage models including: || AEXC202040, IEXC121255, ILXC1212115, ILXC151585, || AEXC222240, IEXC131355, ILXC1212135, ILXC1616115, || AEXC242440, IEXC141455, ILXC121285, ILXC1616135, || AEXC262640, IEXC151555, ILXC1313115, ILXC161685, || AEXC282840, IEXC161655, ILXC1313135, ILXC1620115, || BFXC2012135, IEXC162085, ILXC131385, ILXC1620135, || BFXC2012165, IEXC181855, ILXC1414115, ILXC1818115, || BFXC2213135, IEXC182285, ILXC1414135, ILXC1818135, || BFXC2213165, IEXC182485, ILXC141485, ILXC181885, || BFXC2414135, IEXC202055, ILXC1515115, ILXC1822115, || BFXC2414165, ILXC1515135, ILXC1822135, || BFXC2615135, ILXC1824115, || BFXC2615165, ILXC1824135, || BFXC2816135, ILXC2020115, || BFXC2816165, ILXC2020135, || ILXC202085; || Product is manufactured and distributed by Medtronic, Inc., Santa Rosa, CA 95403
  • Manufacturer


  • Dirección del fabricante
    Medtronic CardioVascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Empresa matriz del fabricante (2017)
  • 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