FDA-Device2026-06-17Class IIPROCESSING DEFECT
Boston Scientific TCN Electrodes recalled for substandard performance
What this means
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.
- 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
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
49,251 units
Manufactured in
25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2026Want us to check the next one for you?
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