Events

Retiro De Equipo (Recall) de Device Recall Diamondback 360 Peripheral 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
    68806
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2155-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-08-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128772
  • 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, peripheral, atherectomy - Product Code MCW
  • Causa
    Csi has initiated a recall on the diamondback 360 peripheral orbital atherectomy device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
  • Acción
    Cardiovascular System, Inc. sent consignees an Urgent Medical Device Recall letter dated May 23, 2014. The letter described the Affected Product, Recall Description, Instructions which included to remove the affected product and return it to CSI and to complete and return the Customer Acknowledgement Form. For further Information they customers were instructed to contact Customer Service, Cardiovascular System, Inc., 877-274-0901. For questions regarding this recall call 877-274-0901.

Device

Device Recall Diamondback 360 Peripheral Orbital Atherectomy System.
  • Modelo / Serial
    100573, 100575, 100674, 100676, 100678, 100680.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
  • Descripción del producto
    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. || The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
  • 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