Events

Recall of Device Recall StarBurst MRI SemiFlex Electrode Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics.

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
    70388
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133427
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
  • Action
    AngioDynamics sent an Urgent Medical Device Recall - Immediate Action Required letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Immediately remove the recall product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Immediately forward a copy of this recall notification to all sites to which you have distributed affected product. If affected product is located in your institution, please call AngioDynamics, Inc. Customer Service at 1-800-772-6446 between 8:00a.m. and 7:00p.m. (Monday- Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) following the directions on this page and the Reply Verification Form.

Device

Device Recall StarBurst MRI SemiFlex Electrode Device
  • Model / Serial
    Lot No. 4773676, 4776428 and 4780110
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of AZ, AR, FL, MI, MN, MO, NY, TX, VA, WA and WI., and to the countries of Hungary and Spain.
  • Product Description
    Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
  • Manufacturer
    Angiodynamics

Manufacturer

Angiodynamics
  • Manufacturer Address
    Angiodynamics, 10 Technical Park, Glens Falls NY 12804
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA