Device recall
Z-0370-06: Medtronic Activa Deep Brain Stimulation (DBS) system including the following…
FDA device recall · Class II · Medtronic Inc, Neurological & Spinal Division
Key facts
| Recall number (Z-number) | Z-0370-06 |
|---|---|
| Recall event | 34156 |
| Product | Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions… |
| Product code | MHY |
| Recalling firm | Medtronic Inc, Neurological & Spinal Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2006 |
| PMA numbers | P960009 |
| FEI number | 2182207 |
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