Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Elec

Recalled June 17, 2026 · FDA recall Z-2403-2026 · Boston Scientific Neuromodulation

Hazard

Reusable electrodes may not meet expected performance levels. · FDA Class II

Units

49,251 units

Sold at

Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

Description

Reusable electrodes may not meet expected performance levels.

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: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

Manufacturer(s)

Boston Scientific Neuromodulation Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →