Events

Retiro De Equipo (Recall) de Device Recall Diamondback 360 Coronary Orbital Atherectomy System

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 Cardiovascular Systems, 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
    67445
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1095-2014
  • Fecha de inicio del evento
    2014-01-27
  • Fecha de publicación del evento
    2014-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125479
  • 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, coronary, atherectomy - Product Code MCX
  • Causa
    Cardio vascular systems inc. has initiated a recall to request the immediate removal and return of diamondback 360 coronary orbital atherectomy device (oad). the device mistakenly contains a saline line that is used in our peripheral atherectomy device. this saline line was not part of the fda approval for use in the coronary device. it therefore does not meet specification for this device. c.
  • Acción
    Cardiovascular Systems Inc. sent an "Urgent Medical Device Recall" letter dated January 27, 2014 to all affected customers. The letter described the affected product, recall description and actions to be taken. Customers were instructed to complete and return the attached Customer Acknowledgement Form and return the device i available. For further information they should contact CSI Customer Service at 651 Campus Drive, Saint Paul, MN 55112, Tele 877-274-0901, Fax 612-677-3355.

Device

Device Recall Diamondback 360 Coronary Orbital Atherectomy System
  • Modelo / Serial
    Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
  • Descripción del producto
    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 || Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • Dirección del fabricante
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Empresa matriz del fabricante (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA