Device recall
Z-2403-2026: Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x…
FDA device recall · Class II · Boston Scientific Neuromodulation Corporation
Key facts
| Recall number (Z-number) | Z-2403-2026 |
|---|---|
| Recall event | 98939 |
| Product | Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF… |
| Product code | GXI |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K050084, K183177 |
| 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