Events

Recall of IntraCoil

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
    48102
  • Event Risk Class
    Class 3
  • Event Number
    Z-1816-2008
  • Event Initiated Date
    2008-04-09
  • Event Date Posted
    2008-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70838
  • 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
    peripheral vascular stent - Product Code NIP
  • Reason
    An intracoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm stent.
  • Action
    ev3 representative visited the consignee on 4/15/08 and spoke to the physician at the site that used the device. A Device Recall Field Action Reconcilliation Form was requested.

Device

IntraCoil
  • Model / Serial
    Lot 4401214
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    CA
  • Product Description
    ev3 The Endovascular Company, IntraCoil Self-Expanding Peripheral Stent, Model REF VT-6-60-135, Lot 4401214, Use Before 2010-07.
  • Manufacturer
    Ev3, Inc

Manufacturer

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