Events

Recall of Medtronic Percutaneous Catheter Introducer Set

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
    Recall
  • Event ID
    50078
  • Event Risk Class
    Class 2
  • Event Number
    Z-0441-2009
  • Event Initiated Date
    2008-10-07
  • Event Date Posted
    2008-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74671
  • 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
    Catheter Introducer - Product Code DYB
  • Reason
    Failure to insert the guidewire through the 18 gauge introducer needle.
  • Action
    Medtronic notified Medtronic Sales representatives via UPS for hand delivery of the Urgent Notification of Product Recall letter to the affected customers on 10/7/08 advising users to segregate the product so that it would not be used. The letter stated that a Medtronic Sales Rep would visit the site to account for all units that were received and would initiate a credit, as appropriate. Customers were requested to cooperate and assist with completing the necessary documentation.

Device

Medtronic Percutaneous Catheter Introducer Set
  • Model / Serial
    Lot Number: 20111256
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of IL and FL, and countries of Belgium, Honduras, and Germany.
  • Product Description
    5 F BardSelect 11 cm Percutaneous Catheter Introducer Set || Ref: 050A11 || Percutaneous catheter introducer sets, including sheath, dilator, guide wire and needle, are used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices. Guide wire introducer needles are used for percutaneous puncture and insertion into the blood vessel. The guide wire is then inserted through the cannula of the introducer needle at the puncture site. The cannula is then removed to allow insertion of the percutaneous catheter introducer following removal of the guide wire introducer needle.
  • Manufacturer
    Medtronic, Inc.

Manufacturer

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