Device recall
Z-1440-2010: Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-1440-2010 |
|---|---|
| Recall event | 54686 |
| Product | Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia… |
| Product code | DXY |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2013 |
| PMA numbers | P980035 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database