Events

Recall of Device Recall Medtronic Paceart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Managment.

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
    39422
  • Event Risk Class
    Class 3
  • Event Number
    Z-0081-2008
  • Event Initiated Date
    2007-08-27
  • Event Date Posted
    2007-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55510
  • 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
    trans-telephonic pacemaker evaluation system - Product Code DPS
  • Reason
    An issue with the paceart system - 2006 first edition (get connected edition) exists. under certain circumstances, paceart system generic icd reports may not accurately reflect patient vt/vf, svt/nst and mode switch/at/af episode detection data. when episode detection data is imported into the paceart system from certain sources, the paceart system generic icd reports display a zero, suggesting.
  • Action
    A Medtronic letter was sent to consignees on 8/27/07. The letter described the issue and the product involved. It also notified customers that Medtronic is developing a software update that will correct the issue. An Acknowledgement form was attached to be filled by consignees as confirmation and understanding of the information received.

Device

Device Recall Medtronic Paceart
  • Model / Serial
    Paceart System - 2006 First Edition (Get Connected Edition)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Source
    USFDA