Events

Recall of Device Recall Protege GPS

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
    29629
  • Event Risk Class
    Class 2
  • Event Number
    Z-1329-04
  • Event Initiated Date
    2004-07-09
  • Event Date Posted
    2004-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34246
  • 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
    Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. an investigation found that 6fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6fr 120 cm (.035') were labeled as 6fr, 135 cm (.018').
  • Action
    Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.

Device

Device Recall Protege GPS
  • Model / Serial
    Lot # 672655
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.
  • Product Description
    Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary)
  • Manufacturer
    Ev3

Manufacturer

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