Device recall
Z-1512-2009: Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive…
FDA device recall · Class I · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-1512-2009 |
|---|---|
| Recall event | 52076 |
| Product | Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306. |
| Product code | DXY |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 28, 2012 |
| PMA numbers | P980035, P980035/S4 |
| 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