Medtronic Inc. Cardiac Rhythm Managment 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 s Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 s
Brand
Medtronic Inc. Cardiac Rhythm Managment
Lot Codes / Batch Numbers
Paceart 2004 second edition and Paceart 2005 first edition
Products Sold
Paceart 2004 second edition and Paceart 2005 first edition
Medtronic Inc. Cardiac Rhythm Managment is recalling Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway S due to The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026