Events

Retiro De Equipo (Recall) de Device Recall IVUS 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 Volcano 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
    71881
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2718-2015
  • Fecha de inicio del evento
    2015-07-22
  • Fecha de publicación del evento
    2015-09-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139266
  • 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 for crossing total occlusions - Product Code PDU
  • Causa
    Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the pioneer plus intravascular ultrasound guided re-entry catheters.
  • Acción
    The Volcano Corporation sent an Urgent Medical Device Recall letter dated July 22, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately quarantine and return all affected product in their inventory. Customers were also asked to complete the attached form and fax back to 866-723-2482. Customers with questions were instructed to call 866-861-8923. For questions regarding this recall call 978-439-3586.

Device

Device Recall IVUS Catheter
  • Modelo / Serial
    Product Code PPLUS20; All lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Canada, Europe, Saudi Arabia, Iran, Egypt, and Qatar.
  • Descripción del producto
    Volcano Pioneer Plus Re-Entry Catheter; || Product Code PPLUS20, Catheter for Crossing Total Occlusions. || Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Dirección del fabricante
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA