Events

Recall of 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
    29996
  • Event Risk Class
    Class 2
  • Event Number
    Z-0008-05
  • Event Initiated Date
    2004-09-01
  • Event Date Posted
    2004-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34967
  • 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 customer complaint received indicated that a prot¿g¿ stent, pn serb65-09-30-120 was found in a pouch that was not properly sealed. the prot¿g¿ gps stent system is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. the pouch seal ensures sterility of the external surface of the inner tray. the inner tray seal containing the device was not affected.
  • Action
    A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.

Device

Protege GPS Biliary Stent System
  • Model / Serial
    SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    South Carolina, North Carolina, and Texas.
  • Product Description
    Biliary Stent System (6Fr 9mm x 30mm).
  • Manufacturer
    Ev3

Manufacturer

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