Moderate riskFDA DeviceJun 17, 2026Class II

Boston Scientific CSK Electrodes recalled for substandard performance

Boston Scientific has recalled certain CSK Electrode models used in neuromodulation procedures because they may not perform reliably as intended. The affected electrodes come in multiple configurations and lengths. No injuries have been reported to date.

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

What to do

If you use or have implanted one of these electrodes (CSK-TC5, CSK-TC10, CSK-TC15, or CSK-TC20 in any cable configuration), contact your healthcare provider or Boston Scientific for guidance.
Do not discard or replace your device without medical advice — your doctor will advise whether continued use is safe or an alternative is needed.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected: 31,923 units
Illnesses reported: None reported
Manufactured in: 25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Classification: Class II
Recall number: Z-2402-2026

In the FDA's words

Description: 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, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm) Reusable electrodes may not meet expected performance levels. All Lots: / UDI: CSK-TC10:00813250010107; CSK-TC10-3M: 00813250011524; CSK-TC15 00813250010114; CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140; CSK-TC5: 00813250010091; CSK-TC5-3M: 00813250011531; Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA. Affected quantity: 31,923 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… (this page)
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…
Z-2403-2026 · 49,251 units