NA TCN-20Recalls & reported problems
Boston Scientific Neuromodulation Corporation · Nitinol TC Electrode, 20cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Apr 29, 2026Open, Classified
Reusable electrodes may not meet expected performance levels.
Z-2403-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other GENERATOR, LESION, RADIOFREQUENCY devices
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- NA TCN-10Boston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY2 recalls54 reports
- NT1100™ RFG-NT-1100St. Jude Medical, Inc. · GENERATOR, LESION, RADIOFREQUENCY107 reports
- NA TCN-15-3MBoston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY2 recalls6 reports
- IonicRF™ RFG-IONICSt. Jude Medical, Inc. · Generator, lesion, radiofrequency105 reports
- NA TCN-5Boston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY2 recalls1 report
- NA CSK-TC10-3MBoston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY1 recall34 reports
- NA CSK-TC15Boston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY1 recall22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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