Events

Retiro De Equipo (Recall) de Device Recall IntraStent DoubleStrut LD Biliary Stent

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 Ev3, 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
    34357
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0829-06
  • Fecha de inicio del evento
    2005-12-29
  • Fecha de publicación del evento
    2006-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43615
  • 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
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Causa
    Intrastent product s15-36 (p/n 90-1341-02) lot 494428 was labeled as intrastent product s15-26 (p/n 90-1341-001).
  • Acción
    On March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents.

Device

Device Recall IntraStent DoubleStrut LD Biliary Stent
  • Modelo / Serial
    Model S15-36, lot no. 494428
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    AR, GA, IN, MA, TN, and UT
  • Descripción del producto
    IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.
  • Manufacturer
    Ev3, Inc

Manufacturer

Ev3, Inc
  • Dirección del fabricante
    Ev3, Inc, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA