Device recall
Z-1190-2013: Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389…
FDA device recall · Class I · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1190-2013 |
|---|---|
| Recall event | 64439 |
| Product | Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for Dystonia, Essential Tremor (ET)… |
| Product code | MHY |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 22, 2014 |
| 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