Reported Jun 17, 2026 · Ongoing
Boston Scientific TCN Electrodes
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
Boston Scientific TCN Electrodes
4 of 4 products
| Model / number | Product as published |
|---|---|
TCN-5 | TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in) |
TCN-15 | REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) , TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in) |
TCN-10-3M | 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) , TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in) |
TCN-20-3M | REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) , TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in) |
- Lot codes and dates
- All Lots/
- UDITCN-10: 00813250013054
- TCN-10-3M00813250017502
- TCN-1500813250013061
- TCN-15-3M00813250017519
- TCN-2000813250013078
- TCN-20-3M00813250017526
- TCN-500813250013047
- TCN-5-3M00813250017533
- Amount recalled
- 49,251 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Reusable electrodes may not meet expected performance levels.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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