Boston Scientific CSK and TCN Electrodes
Boston Scientific CSK Electrodes may not meet expected performance levels.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Boston Scientific Neuromodulation Corporation, of Valencia, California, began a recall on April 29, 2026, of Boston Scientific CSK Electrodes and Boston Scientific TCN Electrodes, because the reusable electrodes may not meet expected performance levels.
The FDA added the recall to its Enforcement Report and classified it on June 11, 2026, with distribution nationwide and worldwide, including the US and countries such as PE, MX, PR, CO, MY, and CA. The CSK Electrodes are stainless steel in lengths of 5, 10, 15, and 20 cm, and the TCN Electrodes are nitinol in lengths of 5, 10, 15, and 20 cm, with some models having 3M cables.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Boston Scientific CSK Electrodes
- UDI-DI
- 00813250010107
- 00813250011524
- 00813250010114
- 00813250011548
- 0081325001140
- 00813250010091
- 00813250011531
- Lot
- All Lots: / UDI: CSK-TC10:00813250010107
Boston Scientific TCN Electrodes
- UDI-DI
- 00813250013054
- 00813250017502
- 00813250013061
- 00813250017519
- 00813250013078
- 00813250017526
- 00813250013047
- 00813250017533
- Lot
- All Lots: / UDI: TCN-10: 00813250013054
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
- Event ID
- 98939
- Recall numbers
- Z-2402-2026 to Z-2403-2026
- Company
- Boston Scientific Neuromodulation CorporationValencia, California
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
All recalls from Boston Scientific Neuromodulation Corporation
