Device recall
Z-2340-2025: Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF…
FDA device recall · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Recall number (Z-number) | Z-2340-2025 |
|---|---|
| Recall event | 96916 |
| Product | Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual |
| Product code | NHL |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P150031 |
| FEI number | 3006630150 |
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