Z-0911-06

Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software...

Name: Z-0911-06 Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2006-02-02
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-02-02 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal... on 2006-02-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0911-06
Status: Terminated
Initiated: 2006-02-02
Posted: 2006-05-31
Terminated: 2006-12-31
Recalling firm: Medtronic, Inc.
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.
Product code: DPS Electrocardiograph
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 root cause: Other
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
Product codes and lots: Paceart 2004 second edition and Paceart 2005 first edition

Product code DPS

K024278Class IIPaceart SystemMedtronic Vascular / cleared 2003-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)