Recall of Device Recall Medtronic AVE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic, 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    The ptca catheter is mislabeled: the curve style (judkin left vs. judkin right ) of the catheter may not correctly match the box label.
  • Action
    Medtronic AVE notified the firm''s sales representatives on 3/17/03 by e-mail to retrieve affected product from the hospital and return it Danvers, MA. Each sales rep. is required to document the notification and accounting for the devices returned from the field.


  • Model / Serial
    Lot Number: 122596
  • Product Classification
  • Distribution
    AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
  • Product Description
    Z2 Guiding Catheter 6 F JR3.5 SH || Item No. : Z26JR35SH
  • Manufacturer


  • Manufacturer Address
    Medtronic, Inc., 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • Source