Boston Scientific Neuromodulation Corporation recalls Boston Scientific TCN Electrodes: REF: TCN-5

Recalling company

Boston Scientific Neuromodulation Corporation

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)

Reason

Reusable electrodes may not meet expected performance levels.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Apr 29, 2026

Reported

Jun 17, 2026

Distribution

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

Status

Ongoing

Quantity

49,251 units

Lot / codes

All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533

Company location

Valencia, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2403-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2403-2026 in the FDA Enforcement Report. Also see FDA recall press releases.