Events

Recall of Protg

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
    26093
  • Event Risk Class
    Class 3
  • Event Number
    Z-0863-03
  • Event Initiated Date
    2003-04-15
  • Event Date Posted
    2003-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27067
  • 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
    The label had an expiration date of august 2005, but the correct expiration date was february 2005.
  • Action
    A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.

Device

Protg
  • Model / Serial
    Lot Number 132612
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide in United States.
  • Product Description
    Prot¿g¿ Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
  • Manufacturer
    ev3, Inc.

Manufacturer

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