Retiro De Equipo (Recall) de Device Recall EKOS EndoWave(TM) Infusion System Drug Delivery Catheter

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 Corp.

¿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
    37314
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0577-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-08
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2008-05-07
  • Fuente del evento
    USFDA
  • 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
    drug delivery catheters - Product Code KRA
  • Causa
    Ekos corporation received three reports that distal radiopaque marker bands on the endowave drug delivery catheter became detached from the catheter during use and remained in the patient.
  • Acción
    On 2/9/07 the firm faxed and sent via certified return receipt an URGENT: Device Recall letter to their consignees. The letters requested to immediately examine stock and segregate all recalled products. In addition, the firm''s representatives will contact, via phone or visit, each of the consignees. Product is to be returned to the firm.

Device

  • Modelo / Serial
    All Models with Serial Number greater than and equal to 0610XXXX-XXX
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA || Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. || EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; || Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Ekos Corp, 11911 N Creek Parkway South, Bothell WA 98011
  • Source
    USFDA