Events

Recall of Amplatz Goose Neck Snare

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
    34337
  • Event Risk Class
    Class 3
  • Event Number
    Z-0894-06
  • Event Initiated Date
    2005-08-16
  • Event Date Posted
    2006-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43565
  • 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
    Microsnare Kit, - Product Code DXE
  • Reason
    Ev3 has determined that one test unit from each of two lots did not meet mininum tensile strength requirements and therefore the entire lots are being recalled.
  • Action
    The recall was initiated on August 16, 2005. All units distributed have been accounted for and the firm completed the recall on December 29, 2005. The firm sent a notification to customers with a Device Recall Field Action Form to record if devices remain at the sight and include with devices returned for credit or replacement.

Device

Amplatz Goose Neck Snare
  • Model / Serial
    Model SK400, Lot number 277755;  Model KS701, Lot number 575327
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AR, CA, CO, FL, IL, KS, MA, MO, NY, PA, TX, WA, VA, Canada, Germany, Japan
  • Product Description
    Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize.------The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device.
  • Manufacturer
    Ev3, Inc

Manufacturer

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