Moderate riskFDA DeviceJun 17, 2026Class II

Boston Scientific TCN Electrodes recalled for substandard performance

Boston Scientific has recalled certain reusable TCN Electrodes used in neuromodulation devices because they may not perform as expected. The affected electrodes come in multiple sizes and configurations, with about 49,251 units distributed worldwide.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

Contact Boston Scientific or your healthcare provider if you use one of these electrodes
Do not discard the device; follow guidance from your provider on next steps
Check the product reference number (TCN-5, TCN-10, TCN-15, TCN-20, or versions with 3M cable) and lot information on your electrode

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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)
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 49,251 units
Illnesses reported: None reported
Manufactured in: 25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Classification: Class II
Recall number: Z-2403-2026

In the FDA's words

Description: 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) Reusable electrodes may not meet expected performance levels. 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 Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. Affected quantity: 49,251 units
Hazard: Reusable electrodes may not meet expected performance levels.

2 products in this recall

Boston Scientific CSK and TCN electrodes recalled for performance risk

Boston Scientific is recalling two lines of reusable electrodes, CSK and TCN, because they may not meet expected performance levels. The recall covers 2 products with about 81,000 units total, distributed across the US and several other countries. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3…
Z-2402-2026 · 31,923 units
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 (0.01… (this page)
Z-2403-2026 · 49,251 units