Events

Retiro De Equipo (Recall) de Device Recall EkoSonic MACH4 Endovascular Device

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 EKOS 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
    62020
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2023-2012
  • Fecha de inicio del evento
    2012-05-24
  • Fecha de publicación del evento
    2012-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109705
  • 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, continuous flush - Product Code KRA
  • Causa
    Ekos corporation have recently received several complaints from users where the radio-opaque marker bands on the intelligent drug delivery catheter (iddc) were dislodged during a procedure and report of microsonic device (msd) breaking during insertion or operation.
  • Acción
    Starting May 25, 2012 to May 31, 2012, EKOS Corporation sent "New warnings in EkoSonic Endovascular Device Instruction for Use" letter, dated May 24, 2012, to all affected customers. Attached with the notification letter is the revised EKOS MACH4 Endovascular Device Instructions for Use in Peripheral Vasculature. Customers are informed of the complaints about the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and reports of the MicroSonic Device (MSD) breaking during insertion or operation. Customers with questions about the revised Instruction for Use, please contact EKOS Corporation at 425-415-3132.

Device

Device Recall EkoSonic MACH4 Endovascular Device
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan.
  • Descripción del producto
    EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). || It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. || All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. || The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". || The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". || EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
  • Manufacturer
    EKOS Corporation

Manufacturer

EKOS Corporation
  • Dirección del fabricante
    EKOS Corporation, 11911 N Creek Pkwy S, Bothell WA 98011-8809
  • Empresa matriz del fabricante (2017)
    Btg Plc
  • Source
    USFDA