Events

Recall of Primus 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
    34352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0442-06
  • Event Initiated Date
    2005-08-01
  • Event Date Posted
    2006-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43605
  • 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 primus device was labeled as a bxb 35 09-37-75 but contained a bxb35 07-27-75 stent.
  • Action
    Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.

Device

Primus GPS Biliary Stent System
  • Model / Serial
    Lot no. 923291, 923290
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
  • Product Description
    Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
  • Manufacturer
    Ev3, Inc

Manufacturer

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