Device recall
Z-1515-2009: Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual…
FDA device recall · Class I · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-1515-2009 |
|---|---|
| Recall event | 52076 |
| Product | Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber Rate Responsive Pacemaker, models KDR601, KDR603, KDR606, KDR651, KDR653, KDR701, KDR703, KDR706, KDR721, and KDR921. |
| Product code | NVZ |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 28, 2012 |
| PMA numbers | P970012, P980035, P980035/S9 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 10–99 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