Events

Recall of Device Recall Intrastent Balloon Expandable Biliary Stent

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
    46693
  • Event Risk Class
    Class 2
  • Event Number
    Z-1129-2008
  • Event Initiated Date
    2008-01-18
  • Event Date Posted
    2008-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67947
  • 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
    Incorrect information on label: specific lots of ev3 intrastent unmounted balloon expandable stents have the two symbols for length and diameter on the side and end flaps reversed.
  • Action
    ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."

Device

Device Recall Intrastent Balloon Expandable Biliary Stent
  • Model / Serial
    Lot Numbers: 3766729 and 2417395
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, || ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000. || ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, || Catalog Number: 90-2337-000 (not approved within USA).
  • Manufacturer
    Ev3, Inc

Manufacturer

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