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Boston Scientific CSK Electrodes
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MEDICAL DEVICE RECALLMODERATE

Boston Scientific CSK Electrodes

Boston Scientific recalls CSK reusable electrodes over performance concerns.

What to do

Check if you have affected CSK electrodes (REF CSK-TC5, CSK-TC5-3M, CSK-TC10, CSK-TC10-3M, CSK-TC15, CSK-TC15-3M, CSK-TC20). Stop using them and contact Boston Scientific for instructions on return and replacement.

Recalled
Listed
Updated
Recall No.
Z-2402-2026
Agency
FDA
Firm
Boston Scientific Neuromodulation Corporation
Recall ID
98939
Status
ONGOING

Why it was recalled

Boston Scientific Neuromodulation Corporation is recalling CSK reusable electrodes because they may not meet expected performance levels, which could affect therapy delivery. The affected electrodes are stainless steel, 28 ga (0.36 mm), in lengths of 5 cm, 10 cm, 15 cm, and 20 cm, with or without a 3M cable.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeRecall #UDI-DI
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–Z-2402-202600813250010107, 00813250011524, 00813250010114, 00813250011548, 0081325001140, 00813250010091, 00813250011531
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 CABL–Z-2403-202600813250013054, 00813250017502, 00813250013061, 00813250017519, 00813250013078, 00813250017526, 00813250013047, 00813250017533
Boston Scientific CSK ElectrodesAll Lots: / UDI: CSK-TC10:00813250010107––
Boston Scientific TCN ElectrodesAll Lots: / UDI: TCN-10: 00813250013054––

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification