Quick Facts at a Glance
- Recall Date
- April 29, 2026
- Hazard Level
- HIGH
- Brand
- Boston Scientific Neuromodulation
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific Neuromodulation
- Model numbers
- All Lots: / UDI: TCN-10: 00813250013054, TCN-10-3M: 00813250017502, TCN-15: 00813250013061, TCN-15-3M: 00813250017519, TCN-20: 00813250013078, TCN-20-3M: 00813250017526, TCN-5: 00813250013047, TCN-5-3M:00813250017533
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 29, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reusable electrodes may not meet expected performance levels.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Neuromodulation Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
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). Reason: Reusable electrodes may not meet expected performance levels.. Classification: Class II. Quantity: 49,251 units. Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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