Events

Recall of Device Recall Medtronic Paceart software

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
    35141
  • Event Risk Class
    Class 3
  • Event Number
    Z-0911-06
  • Event Initiated Date
    2006-02-02
  • Event Date Posted
    2006-05-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45402
  • 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
    Cardiac Rhythm collection system - Product Code DPS
  • Reason
    The paceart system could inappropriately insert data from a patient's medtronic carelink transmission into another patient's paceart record. an issue associated with the automated batch transfer of implanted cardiac device data from the medtronic carelink network to the paceart system exists.
  • Action
    Affected user and potential users of the Gateway product were notified via phone and/ or a customer notification. The notification offers interim options until a software update is available. Customers are asked to respond back to Metronic with an enclosed Acknowledgement form.

Device

Device Recall Medtronic Paceart software
  • Model / Serial
    Paceart 2004 second edition and Paceart 2005 first edition
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.
  • 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