Boston Scientific Neuromodulation Corporation: Probe, Radiofrequency Lesion
Boston Scientific is recalling several models of CSK Electrodes used in radiofrequency lesion procedures because the reusable electrodes may not perform as expected. The affected products are distributed nationwide in the US and in several other countries including Canada, Mexico, and Peru. This is a Class II recall, which indicates a potential health issue though not an immediate serious risk.
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- 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)
- Reason
- Reusable electrodes may not meet expected performance levels.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6ffa4d8f-33b6-46a9-9fcc-a47f435784f0