Official recall notice
FDA DeviceClass IINotable
FDA Recall: Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);
- Recall date
- 2026-06-17
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Reusable electrodes may not meet expected performance levels.
Recommended action
What to do
49,251 units
Product description
Reusable electrodes may not meet expected performance levels.