Device recall
Z-2694-2026: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS…
FDA device recall · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Recall number (Z-number) | Z-2694-2026 |
|---|---|
| Recall event | 98933 |
| Product | Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS… |
| Product code | GXI |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K222281 |
| FEI number | 3006630150 |
At a glance
- 1–9 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