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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic Paceart software

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  Class 3 Device Recall Medtronic Paceart software see related information
Date Initiated by Firm February 02, 2006
Date Posted May 31, 2006
Recall Status1 Terminated 3 on December 31, 2006
Recall Number Z-0911-06
Recall Event ID 35141
510(K)Number K024278  
Product Classification Cardiac Rhythm collection system - Product Code DPS
Product 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.
Code Information Paceart 2004 second edition and Paceart 2005 first edition
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Minneapolis MN 55432-3568
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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.
Quantity in Commerce 210
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = MEDTRONIC VASCULAR