Events

Recall of Device Recall ev3 Primus GPS Biliary Stent and Delivery 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
    34884
  • Event Risk Class
    Class 2
  • Event Number
    Z-0912-06
  • Event Initiated Date
    2006-03-08
  • Event Date Posted
    2006-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44886
  • 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 Stent - Product Code FGE
  • Reason
    A primus device labeled (pouch and box) as a bxb35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
  • Action
    ev3 field representatives visited all affected accounts. Product was retrieved a 'Field Action Form' was completed and a copy was left with the account.

Device

Device Recall ev3 Primus GPS Biliary Stent and Delivery System
  • Model / Serial
    Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV
  • Product Description
    ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.
  • Manufacturer
    Ev3, Inc

Manufacturer

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