Device recall
Z-1110-04: Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Managment
Key facts
| Recall number (Z-number) | Z-1110-04 |
|---|---|
| Recall event | 29392 |
| Product | Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 901 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also… |
| Product code | DXY |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Managment |
| Recall class | Class II |
| Status | Terminated on November 03, 2005 |
| 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