Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The Pacea
FDA device recall Z-0081-2008 · posted 2007-11-06 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 721
- Distribution
- Nationwide.
- Date initiated
- 2007-08-27
- Date posted
- 2007-11-06
- Date terminated
- 2008-11-03
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PACEART SYSTEM (K024278) | Medtronic Vascular | 2003-05-29 |