Events

Recall of Device Recall Protege GPS Biliary Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ev3.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32459
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-05
  • Event Initiated Date
    2005-06-10
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40126
  • Notes / Alerts
    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.
  • Extra notes in the data
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • Reason
    A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. affected product was retrieved by an ev3 representative.
  • Action
    ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.

Device

Device Recall Protege GPS Biliary Stent System
  • Model / Serial
    Lot 117182
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    FL and PA
  • Product Description
    ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
  • Manufacturer
    Ev3

Manufacturer

Ev3
  • Manufacturer Address
    Ev3, 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Source
    USFDA