FDA-Device2026-06-17Class IIPROCESSING DEFECT
Boston Scientific CSK Electrodes recalled for substandard performance
What this means
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.
- 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.
The agency's original wording
Hazard
Reusable electrodes may not meet expected performance levels.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Affected count
31,923 units
Manufactured in
25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2026Want us to check the next one for you?
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