Events

Recall of Device Recall ParaMount Mini GPS

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
    28210
  • Event Risk Class
    Class 2
  • Event Number
    Z-0598-04
  • Event Initiated Date
    2004-01-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31682
  • 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
    After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time.
  • Action
    A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives.

Device

Device Recall ParaMount Mini GPS
  • Model / Serial
    Lots 262849 through 445216
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed nationwide in the United States and internationally to China and Ireland.
  • Product Description
    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery system 5mm x 14mm 80 cm .014" REF PMP4-5-14-80
  • Manufacturer
    ev3, Inc.

Manufacturer

ev3, Inc.
  • Manufacturer Address
    ev3, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Source
    USFDA