NA RF-NE-15Recalls & reported problems
St. Jude Medical, Inc. · REUSABLE NITINOL RF ELECTRODE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067025197), received between Oct 23, 2018 and Mar 2, 2023 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Impedance Problem” (2 reports).
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.
Most reported problems
Device problems
- Impedance Problem2
- Insufficient Heating2
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2023Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT DURING THE PROCEDURE, THE PROBE CAUSED CAUTERIZATION OF TISSUE RESULTING IN DIFFICULT REMOVAL AND WAS NOT HEATING TO TEMPERATURE. THE PROBE WAS REPLACED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16475739 ↗InjuryFeb 28, 2023Impedance Problem; Impedance Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3004617090-2023-00002 IT WAS REPORTED THAT THE PROBE WERE NON FUNCTION DUE TO IMPEDANCE ISSUE. AS SUCH, THE PROCEDURE WAS NOT COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456961 ↗InjuryFeb 28, 2023Impedance Problem; Impedance Problem
RELATED MANUFACTURER REFERENCE NUMBER: 3004617090-2023-00001. IT WAS REPORTED THAT THE PROBE WERE NON FUNCTION DUE TO IMPEDANCE ISSUE. AS SUCH, THE PROCEDURE WAS NOT COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16456322 ↗MalfunctionJun 10, 2021Insufficient Heating; Insufficient Heating
DURING THE PROCEDURE, THE PROBE WOULD NOT HEAT UP TO THE APPROPRIATE TEMPERATURE AND THE PROCEDURE WAS THEN CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980719 ↗MalfunctionOct 23, 2018Smoking; Smoking
DURING TESTING SMOKE WAS EMITTING FROM THE TIP OF THE ELECTRODE. THERE WERE NO ADVERSE CONSEQUENCES TO A USER OR PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7996084 ↗
Other PROBE, RADIOFREQUENCY LESION devices
- NA TCN-15Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls10 reports
- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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