Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtron
FDA device recall Z-0911-06 · posted 2006-05-31 · Terminated
Recall details
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Managment
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPS
- Quantity affected
- 210
- Distribution
- Nationwide
- Date initiated
- 2006-02-02
- Date posted
- 2006-05-31
- Date terminated
- 2006-12-31
- 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 |