Z-0081-2008

Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604...

Name: Z-0081-2008 Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2007-08-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2007-08-27 / Terminated / root cause: software

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Paceart System can act as a Practice... on 2007-08-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0081-2008
Status: Terminated
Initiated: 2007-08-27
Posted: 2007-11-06
Terminated: 2008-11-03
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: DPS Electrocardiograph
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 721
Distribution: Nationwide.
Product codes and lots: Paceart System - 2006 First Edition (Get Connected 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)