Device recall
Z-1191-2013: Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339…
FDA device recall · Class I · Medtronic Neuromodulation
Key facts
| Recall number (Z-number) | Z-1191-2013 |
|---|---|
| Recall event | 64439 |
| Product | Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic… |
| Product code | MRU |
| Recalling firm | Medtronic Neuromodulation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 22, 2014 |
| FEI number | 2182207 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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