NA RF-NE-10Recalls & 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 05415067025180), received between Nov 22, 2019 and Nov 19, 2020 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Smoking” (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
- Smoking2
- Break1
- Communication or Transmission Problem1
- Insufficient Heating1
Patient problems
- No Consequences Or Impact To Patient3
- No Patient Involvement2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2020Insufficient Heating; Insufficient Heating
DURING A RADIOFREQUENCY ABLATION PROCEDURE, THE PROBE DID NOT REACH THE APPROPRIATE THERAPY TEMPERATURE AND THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE CANCELLATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10871644 ↗InjurySep 2, 2020Communication or Transmission Problem; Communication or Transmission Problem
DURING DEVICE PREPARATION, WHEN THE PROBE WAS CONNECTED TO THE GENERATOR, THE GENERATOR WOULD BEEP AND THE SCREEN WOULD LOCK UP. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. THE PATIENT WAS ALREADY PREPARED FOR THE PROCEDURE WHEN THE CASE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10481854 ↗MalfunctionFeb 24, 2020Smoking; Smoking
RELATED MANUFACTURING REF: 3004617090-2020-00002. DURING DEVICE TESTING, THE PROBES STARTED SMOKING WHEN TESTING ON THE GROUNDING PAD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9744198 ↗MalfunctionFeb 24, 2020Smoking; Smoking
RELATED MANUFACTURING REF: 3004617090-2020-00003. DURING DEVICE TESTING, THE PROBES STARTED SMOKING WHEN TESTING ON THE GROUNDING PAD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9744181 ↗MalfunctionNov 22, 2019Break; Break
THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9365173 ↗
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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