IonicRF™ RFG-IONICRecalls & reported problems
St. Jude Medical, Inc. · Generator · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude IonicRF radiofrequency generator is the power unit used in radiofrequency ablation procedures. Its 104 reports, 47 of them injuries, often describe grounding pad warnings, probes not being recognized, overheating and procedures being abandoned, and one report lists a third-degree burn. There were no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 05415067029317), received between Nov 17, 2020 and Sep 29, 2026 — classified as 48 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Output Problem” (27 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem27
- Insufficient Heating24
- Connection Problem10
- Grounding Malfunction8
- Communication or Transmission Problem7
- Temperature Problem6
- Adverse Event Without Identified Device or Use Problem5
- Unexpected Shutdown4
Patient problems
- No Clinical Signs, Symptoms or Conditions98
- Muscle Weakness/Atrophy2
- Pain2
- Speech Disorder2
- Burning Sensation1
- Electric Shock1
- Full thickness (Third Degree) Burn1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Device Remains Activated
It was reported the patient displayed muscle spasms without the device being turned on. No adverse patient consequences were reported, but the procedure was abandoned after the probe had been inserted in the patient.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50933628 ↗InjurySep 24, 2026Unintended Electrical Shock
It was reported that during ablation procedure, patient experienced unintended shocks. As result, the procedure was abandoned to address the issue.
Patient problems: Pain
MAUDE report 50889540 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503222 ↗MalfunctionAug 11, 2026Communication or Transmission Problem
It was reported the device was not recognizing the probes and overheating issue. The procedure was aborted as a result and there were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212510 ↗InjuryAug 7, 2026Grounding Malfunction
It was reported that during an RFA procedure there was a grounding pad malfunction that was unable to be cleared, and the procedure was aborted. The patient experienced no consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182318 ↗InjuryMar 30, 2026Temperature Problem
IT WAS REPORTED THAT DURING THE RF ABLATION THE PROBE TEMPERATURE DROPPED THEN SHOT UP AND THE MACHINE REGISTERED OVER TEMPERATURE ON CHANEL [X]. GROUNDING PAD DETACHED MESSAGE WAS ALSO REPORTED. TROUBLESHOOTING RESOLVED THE GROUNDING PAD MESSAGE, BUT THE TEMPERATURE MESSAGE WAS NOT RESOLVED. AS A RESULT, THE PROCEDURE WAS ABANDONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24720979 ↗MalfunctionMar 13, 2026Insufficient Heating
IT WAS REPORTED THAT DURING AN RFA PROCEDURE, A MESSAGE WAS SEEN DURING A PROCEDURE. TROUBLESHOOTING WAS DONE BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24587655 ↗InjuryFeb 6, 2026Grounding Malfunction
IT WAS REPORTED THAT THERE WAS A GROUNDING PAD MALFUNCTION DURING THE RFA PROCEDURE AND AS A RESULT, THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283425 ↗InjuryJan 13, 2026Impedance Problem
IT WAS REPORTED THAT DURING A PROCEDURE THE GENERATOR EXPERIENCED IMPEDANCE ERRORS. AS A RESULT, THE PROCEDURE WAS ABANDONED WITH NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059728 ↗InjuryJan 13, 2026Unexpected Shutdown
IT WAS REPORTED THAT DURING AN RFA PROCEDURE, THE GENERATOR UNEXPECTEDLY SHUT DOWN, AND THE PROCEDURE WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058958 ↗InjuryJan 5, 2026Grounding Malfunction
IT WAS REPORTED THAT THERE WAS A GROUNDING PAD MALFUNCTION DURING THE RFA PROCEDURE AND AS A RESULT, THE PROCEDURE WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23962906 ↗MalfunctionDec 22, 2025Insufficient Heating; Insufficient Heating
IT WAS REPORTED THE GENERATOR CANNOT REACH TARGET TEMPERATURE DURING RFA PROCEDURE, AND EVENTUALLY DISCONNECTED. AS A RESULT, THE PROCEDURE WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23873365 ↗InjuryNov 26, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE GROUNDING PAD TEST FAILED REPEATEDLY. AS A RESULT, THE PROCEDURE WAS ABORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23660483 ↗MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A RADIOFREQUENCY LESIONING PROCEDURE PATIENT EXPERIENCED A SUPERFICIAL SKIN BURN, SUBSEQUENTLY LEADING TO LOCALIZED SOFT TISSUE NECROSIS. AS A RESULT, EXTENDED WOUND CARE WAS DONE TO ADDRESS THE ISSUE. PATIENT IS STABLE.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 23584229 ↗MalfunctionNov 12, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AFTER 50 NERVE PULSES, THE DEVICE STOPPED WORKING WITH AN ERROR MESSAGE FAILING TO RECOGNIZE THE ELECTRODE. THE ELECTRODE WAS REPLACED BUT ISSUE PERSISTED. THE INSERTION PORTS WERE THEN SWITCHED HOWEVER HIGH IMPEDANCES WERE STILL PRESENT. THE PROCEDURE WAS THEN ABANDONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23535988 ↗MalfunctionNov 11, 2025Insufficient Heating; Insufficient Heating
IT WAS REPORTED AN RFA PROCEDURE WAS ABANDONED DUE TO GENERATOR WOULD NOT REACH A SUFFICIENT TEMPERATURE AND WOULD NOT GENERATE A LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23521914 ↗InjurySep 17, 2025Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE PATIENT'S PROCEDURE WAS ABANDONED DUE TO AN UNEXPECTED SHUTDOWN WITH THE GENERATOR. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075874 ↗InjuryAug 6, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THE PROCEDURE WAS ABANDONED DUE TO CONNECTION ISSUES WITH THE GROUNDING PAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22734514 ↗MalfunctionJul 21, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION PROCEDURE ON (B)(6) 2025, THE GENERATOR WILL NOT RECOGNIZE THE GROUNDING PAD AFTER MULTIPLE ATTEMPTS. THE GENERATOR EXCEEDED MAXIMUM TEMPERATURE AND THE PROCEDURE WAS ABANDONED. THERE WERE NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561457 ↗MalfunctionJul 17, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING AN RFA PROCEDURE, AN ERROR WAS DISPLAYED DUE TO GROUNDING PAD NOT ATTACHING. TROUBLESHOOTING WAS DONE BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22532417 ↗InjuryJul 15, 2025Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AN UNKNOWN ERROR WITH THE IONIC GENERATOR CAUSED THE PROCEDURE TO BE ABANDONED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22511893 ↗MalfunctionJun 26, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT DURING AN RFA PROCEDURE, MULTIPLE PROBES WERE NOT REACHING TEMPERATURE. TROUBLESHOOTING WAS DONE BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342816 ↗MalfunctionJun 26, 2025Temperature Problem; Temperature Problem
IT WAS REPORTED THAT DURING AN RFA PROCEDURE, MULTIPLE PROBES WERE NOT REACHING TEMPERATURE. TROUBLESHOOTING WAS DONE BUT THE ISSUE PERSISTED. THE PROCEDURE WAS ABANDONED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22342814 ↗InjuryJun 11, 2025Insufficient Heating; Insufficient Heating
IT WAS REPORTED THAT THE GENERATOR WAS UNABLE TO REACH THE CORRECT TEMPERATURE. THE PROCEDURE WAS ABANDONED AS A RESULT. NO ADVERSE CONSEQUENCES WERE REPORTED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22191393 ↗InjuryJun 8, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DURING A PROCEDURE. IT WAS ALSO REPORTED THAT THE GENERATOR HAD HIGH IMPEDANCES. NO OTHER ADVERSE EFFECTS WERE NOTED.
Patient problems: Pain
MAUDE report 22164475 ↗
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
- 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
- NA CSK-TC15-3MBoston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY1 recall7 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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