NA RF-SE-10Recalls & reported problems
St. Jude Medical, Inc. · REUSABLE RF ELECTRODE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05415067025227), received between Dec 10, 2018 and Feb 27, 2024 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Heating” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Heating2
- Temperature Problem2
- Thermal Decomposition of Device2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Deliver Energy1
- Melted1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient2
- Partial thickness (Second Degree) Burn2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2024Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT DURING THE START OF AN ABLATION PROCEDURE, THE PROBE WAS NOT REGISTERING IN ANY OF THE PORTS. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18787875 ↗InjuryOct 12, 2023Thermal Decomposition of Device; No Apparent Adverse Event; Thermal Decomposition of Device; No Apparent Adverse Event
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE BURN WAS ONLY AT ONE SITE OF INSERTION. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE PROBE ATTRIBUTED TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions; Partial thickness (Second Degree) Burn
MAUDE report 17925015 ↗InjuryOct 6, 2023Thermal Decomposition of Device; Adverse Event Without Identified Device or Use Problem; Thermal Decomposition of Device; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE BURN WAS ONLY AT ONE SITE OF INSERTION. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE PROBE ATTRIBUTED TO THE ISSUE.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 17890360 ↗InjuryJun 22, 2023Insufficient Heating; Insufficient Heating
RELATED MANUFACTURER REFERENCE NUMBER: 3004617090-2023-00005. IT WAS REPORTED THAT DURING A PROCEDURE THE PROBES DID NOT PROPERLY HEAT TO DESIRED TEMPERATURE. AS SUCH, THE PROCEDURE WAS NOT COMPLETED. REPORTEDLY, THE DOCTOR HAD ATTEMPTED TO INSERT THE PROBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183122 ↗MalfunctionJun 22, 2023Insufficient Heating; Insufficient Heating
RELATED MANUFACTURER REFERENCE NUMBER: 3004617090-2023-00006. IT WAS REPORTED THAT DURING A PROCEDURE THE PROBES DID NOT PROPERLY HEAT TO DESIRED TEMPERATURE. AS SUCH, THE PROCEDURE WAS NOT COMPLETED. REPORTEDLY, THE DOCTOR HAD ATTEMPTED TO INSERT THE PROBES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17183114 ↗InjuryDec 10, 2018Temperature Problem; Temperature Problem
RELATED MANUFACTURER REPORT NUMBER: 3004617090-2018-00010, 3002953813-2018-00091. DURING A BI-POLAR ABLATION PROCEDURE, THE PROBES CONNECTED TO PORTS 1 AND 2 DID NOT REACH TEMPERATURE AND ONE OF THE PROBES MELTED. THE PROBES WERE REPLACED, THE GENERATOR WAS POWER CYCLED, AND THE OUTLET CHANGED, BUT THE TEMPERATURE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED, BUT THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8148763 ↗InjuryDec 10, 2018Melted; Temperature Problem; Melted; Temperature Problem
RELATED MANUFACTURER REPORT NUMBER: 3002953813-2018-00091, 3004617090-2018-00011. DURING A BI-POLAR ABLATION PROCEDURE, THE PROBES CONNECTED TO PORTS 1 AND 2 DID NOT REACH TEMPERATURE AND ONE OF THE PROBES MELTED. THE PROBES WERE REPLACED, THE GENERATOR WAS POWER CYCLED, AND THE OUTLET CHANGED, BUT THE TEMPERATURE ISSUE REMAINED. THE PROCEDURE WAS CANCELLED, BUT THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8148750 ↗
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
- Intracept RLV 0075Relievant Medsystems, Inc. · 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 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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