Events

Recall of Vortex VX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rita Medical Systems, 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
    45404
  • Event Risk Class
    Class 2
  • Event Number
    Z-0149-2008
  • Event Initiated Date
    2007-10-03
  • Event Date Posted
    2007-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65382
  • 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
    Vascular System Port Kit - Product Code LJT
  • Reason
    Incorrect size catheter: the product may contain an incorrect size catheter.
  • Action
    Notification of the AngioDynamics, Inc. sales force and the domestic and international distributors began on 10/3/2007. Starting on 10/09/2007, Urgent Medical Device Recall letters were sent to all customers requesting that device useage cease and immediate return begin as well as the completion of a fax back form (number of devices used, number to be returned).

Device

Vortex VX
  • Model / Serial
    Lot #: 30938
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.
  • Product Description
    Vortex¿ VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
  • Manufacturer
    Rita Medical Systems, Inc.

Manufacturer

Rita Medical Systems, Inc.
  • Manufacturer Address
    Rita Medical Systems, Inc., 1 Horizon Way, Manchester GA 31816-1749
  • Source
    USFDA