Events

Recall of Device Recall Amplatz Goose Neck Snare Kit

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
    38052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0992-2007
  • Event Initiated Date
    2007-05-18
  • Event Date Posted
    2007-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52862
  • 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
    endovascular instrument - Product Code DXE
  • Reason
    Amplatz goose neck snare kit's catheter contained in the kit may be 4 fr instead of the intended 6 fr.
  • Action
    Letter May 18, 2007.

Device

Device Recall Amplatz Goose Neck Snare Kit
  • Model / Serial
    Lot # 1650307
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen.
  • Product Description
    Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO || ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA || THE ENDOVASCULAR COMPANY. || The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". || Snare Catheter
  • Manufacturer
    Ev3, Inc

Manufacturer

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