Device recall
Z-0536-06: Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Managment
Key facts
| Recall number (Z-number) | Z-0536-06 |
|---|---|
| Recall event | 34093 |
| Product | Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303. |
| Product code | DXY |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Managment |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 4, 2007 |
| PMA numbers | P980035, P980035S002 |
| 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