Events

Recall of Protg 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, Inc.

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
    48614
  • Event Risk Class
    Class 2
  • Event Number
    Z-2169-2008
  • Event Initiated Date
    2008-04-22
  • Event Date Posted
    2008-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71726
  • 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
    Biliary catheter - Product Code FGE
  • Reason
    A protege ps biliary stent system was mislabeled. the mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
  • Action
    The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.

Device

Protg GPS" Biliary Stent System
  • Model / Serial
    Lot 2675311
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- state of LA.
  • Product Description
    Ev3 Protege GPS Biliary Stent Systems || 6 mm, 60 mm, 120cm, .35, 6Fr, OTW || Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 || REF SERB65-06-60-120 || Lot 2675311 || Use before 2009-01-01 || Sterile EO || Intended as a palliative treatment of malignant neoplasms in the biliary tree.
  • Manufacturer
    Ev3, Inc

Manufacturer

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