Events

Retiro De Equipo (Recall) de Medtronic Percutaneous Catheter Introducer Set

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 Medtronic, 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
    50078
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0443-2009
  • Fecha de inicio del evento
    2008-10-07
  • Fecha de publicación del evento
    2008-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74673
  • 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 Introducer - Product Code DYB
  • Causa
    Failure to insert the guidewire through the 18 gauge introducer needle.
  • Acción
    Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.

Device

Medtronic Percutaneous Catheter Introducer Set
  • Modelo / Serial
    Lot Number: 21111255
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • Descripción del producto
    7 F BardSelect 11cm Percutaneous Catheter Introducer Set || Ref: 070A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • Manufacturer
    Medtronic, Inc.

Manufacturer

Medtronic, Inc.
  • Dirección del fabricante
    Medtronic, Inc., 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Source
    USFDA