NA CSK-TC10Recalls & reported problems
Boston Scientific Neuromodulation Corporation · CSK TC Electrode, 10cm · 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.
Quick summary
This Boston Scientific CSK TC10 radiofrequency lesioning probe is a reusable electrode used during pain-relief ablation procedures. Most reports describe the electrode tip breaking off or separating from its hub or connector, sometimes inside the patient, along with heating that does not reach the intended level and leaking. There are 58 reports, including 1 death and 4 injuries; patients mention headache, dizziness, itching and blisters after the procedure. One open recall, started in April 2026, says the reusable electrodes may not meet expected performance levels.
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
- 58
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00813250010107), received between Jun 6, 2017 and Sep 18, 2024 — classified as 1 death, 4 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Material Separation” (18 reports).
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.
Reports received per month
Recalls naming this device
- Apr 29, 2026Open, Classified
Reusable electrodes may not meet expected performance levels.
Z-2402-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Separation18
- Break7
- Insufficient Heating7
- Adverse Event Without Identified Device or Use Problem6
- Defective Device4
- Leak/Splash4
- Fluid/Blood Leak3
- Structural Problem3
Patient problems
- No Known Impact Or Consequence To Patient36
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient5
- Discomfort3
- Dizziness3
- Headache3
- Burn(s)1
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED BLISTERS ON THE LEFT SCAPULA AREA ACCOMPANIED BY ITCHING FOLLOWING THE PROCEDURE. THE PATIENT WAS REFERRED TO HOME HEALTH AND WAS DOING WELL.
Patient problems: Burn(s); Hypersensitivity/Allergic reaction
MAUDE report 20244277 ↗MalfunctionAug 12, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19967036 ↗MalfunctionAug 12, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19967031 ↗MalfunctionAug 12, 2024Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RADIOFREQUENCY ABLATION (RFA) PROCEDURE DURING WHICH AN ELECTRODE BECAME DETACHED FROM THE CONNECTOR WHILE INSIDE THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19966545 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A COMPETITORS DEVICE IMPLANTED PRIOR TO THE RADIOFREQUENCY ABLATION (RFA) PROCEDURE. AFTER THE RFA PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PATIENT OBSERVED THE IMPLANTED DEVICE SETTINGS HAD CHANGED UNEXPECTEDLY WITHOUT INTERVENTION. ADDITIONALLY, A WEEK AFTER THE RFA PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF HEADACHE, DIZZINESS, AND DISCOMFORT. THE PAIN PHYSICIAN ASSUMED THESE CHANGES WERE RELATED TO THE RFA PROCEDURE HOWEVER, THE NEUROSURGEON ASSESSED THAT THE IMPLANTED DEVICE APPEARED TO BE FUNCTIONING NORMALLY. DESPITE THIS, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE TO REPLACE THE COMPETITORS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
Patient problems: Discomfort; Dizziness; Headache
MAUDE report 19822326 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A COMPETITORS DEVICE IMPLANTED PRIOR TO THE RADIOFREQUENCY ABLATION (RFA) PROCEDURE. AFTER THE RFA PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PATIENT OBSERVED THE IMPLANTED DEVICE SETTINGS HAD CHANGED UNEXPECTEDLY WITHOUT INTERVENTION. ADDITIONALLY, A WEEK AFTER THE RF PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF HEADACHE, DIZZINESS, AND DISCOMFORT. THE PAIN PHYSICIAN ASSUMED THESE CHANGES WERE RELATED TO THE RF PROCEDURE HOWEVER, THE NEUROSURGEON ASSESSED THAT THE IMPLANTED DEVICE APPEARED TO BE FUNCTIONING NORMALLY. DESPITE THIS, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE TO REPLACE THE COMPETITORS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
Patient problems: Discomfort; Dizziness; Headache
MAUDE report 19822323 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A COMPETITORS DEVICE IMPLANTED PRIOR TO THE RADIOFREQUENCY ABLATION (RFA) PROCEDURE. AFTER THE RFA PROCEDURE WAS COMPLETED SUCCESSFULLY, THE PATIENT OBSERVED THE IMPLANTED DEVICE SETTINGS HAD CHANGED UNEXPECTEDLY WITHOUT INTERVENTION. ADDITIONALLY, A WEEK AFTER THE RFA PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF HEADACHE, DIZZINESS, AND DISCOMFORT. THE PAIN PHYSICIAN ASSUMED THESE CHANGES WERE RELATED TO THE RFA PROCEDURE HOWEVER, THE NEUROSURGEON ASSESSED THAT THE IMPLANTED DEVICE APPEARED TO BE FUNCTIONING NORMALLY. DESPITE THIS, THE PATIENT WAS HOSPITALIZED AND UNDERWENT A REVISION PROCEDURE TO REPLACE THE COMPETITORS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY.
Patient problems: Discomfort; Dizziness; Headache
MAUDE report 19822322 ↗MalfunctionFeb 20, 2023Defective Device; Defective Device
IT WAS REPORTED THAT THE ELECTRODE WAS BROKEN AND WAS SEPARATED FROM THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16404896 ↗MalfunctionDec 30, 2022Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem
IT WAS REPORTED THAT THE ELECTRODE WAS BROKEN AT THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16077228 ↗MalfunctionAug 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE FACILITY THAT DURING THE STERILIZATION PROCESS THE CENTRAL STERILIZATION TECHNICIAN NOTICED LIQUID SEEPING OUT OF THE BASE OF THE ELECTRODE WHERE THE PROBE WAS ATTACHED. THIS WAS NOTICED AFTER THE ELECTRODE WAS USED IN ONE PROCEDURE ONLY. THEY SUSPECTED THE LIQUID WAS BLOOD AS THE LIQUID WAS RED IN COLOR AND THEY DID NOT REUSE THE ELECTRODE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8852982 ↗MalfunctionMay 1, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE FACILITY THAT DURING THE STERILIZATION PROCESS THE CENTRAL STERILIZATION TECHNICIAN NOTICED LIQUID SEEPING OUT OF THE BASE OF THE ELECTRODE WHERE THE PROBE WAS ATTACHED. THIS WAS NOTICED AFTER THE ELECTRODE WAS USED IN ONE PROCEDURE ONLY. THEY SUSPECTED THE LIQUID WAS BLOOD AS THE LIQUID WAS RED IN COLOR AND THEY DID NOT REUSE THE ELECTRODE.
Patient problems: No Patient Involvement
MAUDE report 8571698 ↗MalfunctionMay 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE FACILITY THAT DURING THE STERILIZATION PROCESS THE CENTRAL STERILIZATION TECHNICIAN NOTICED LIQUID SEEPING OUT OF THE BASE OF THE ELECTRODE WHERE THE PROBE WAS ATTACHED. THIS WAS NOTICED AFTER THE ELECTRODE WAS USED IN ONE PROCEDURE ONLY. THEY SUSPECTED THE LIQUID WAS BLOOD AS THE LIQUID WAS RED IN COLOR AND THEY DID NOT REUSE THE ELECTRODE.
Patient problems: No Patient Involvement
MAUDE report 8571596 ↗MalfunctionMay 1, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED BY THE FACILITY THAT DURING THE STERILIZATION PROCESS THE CENTRAL STERILIZATION TECHNICIAN NOTICED LIQUID SEEPING OUT OF THE BASE OF THE ELECTRODE WHERE THE PROBE WAS ATTACHED. THIS WAS NOTICED AFTER THE ELECTRODE WAS USED IN ONE PROCEDURE ONLY. THEY SUSPECTED THE LIQUID WAS BLOOD AS THE LIQUID WAS RED IN COLOR AND THEY DID NOT REUSE THE ELECTRODE.
Patient problems: No Patient Involvement
MAUDE report 8571591 ↗MalfunctionMay 1, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE FACILITY THAT DURING THE STERILIZATION PROCESS THE CENTRAL STERILIZATION TECHNICIAN NOTICED LIQUID SEEPING OUT OF THE BASE OF THE ELECTRODE WHERE THE PROBE WAS ATTACHED. THIS WAS NOTICED AFTER THE ELECTRODE WAS USED IN ONE PROCEDURE ONLY. THEY SUSPECTED THE LIQUID WAS BLOOD AS THE LIQUID WAS RED IN COLOR AND THEY DID NOT REUSE THE ELECTRODE.
Patient problems: No Patient Involvement
MAUDE report 8571578 ↗MalfunctionNov 15, 2018Insufficient Heating; Insufficient Heating
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODES FOUND THAT THE SHAFT OF THE ELECTRODE WAS SEPARATED FROM THE HUB. THE DAMAGE WAS LIKELY DUE TO UNINTENDED EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8075128 ↗MalfunctionNov 15, 2018Insufficient Heating; Insufficient Heating
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODES FOUND THAT THE SHAFT OF THE ELECTRODE WAS SEPARATED FROM THE HUB. THE DAMAGE WAS LIKELY DUE TO UNINTENDED EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8074563 ↗MalfunctionOct 31, 2018Defective Device; Defective Device
A REPORT WAS RECEIVED THAT THE ELECTRODE WAS BROKEN. THE SHAFT BROKE OFF THE HUB.
Patient problems: No Patient Involvement
MAUDE report 8026727 ↗MalfunctionOct 2, 2018Insufficient Heating; Insufficient Heating
A REPORT WAS RECEIVED THAT THE RETURNED ELECTRODE REVEALED THAT THE SHAFT HAD BECOME SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Patient Involvement
MAUDE report 7926953 ↗MalfunctionSep 19, 2018Insufficient Heating; Insufficient Heating
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED DAMAGED ELECTRODE THAT WAS NOT HEATING. THE COMPLAINT WAS CONFIRMED. THE SHAFT OF THE ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB. THE PROBABLE CAUSE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT. THE SEPARATED SHAFT WAS LIKELY DUE TO UNINTENDED EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7892118 ↗MalfunctionSep 19, 2018Insufficient Heating; Insufficient Heating
A REPORT WAS RECEIVED THAT THE RETURNED ELECTRODE REVEALED THE RETURNED ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7889938 ↗MalfunctionSep 19, 2018Insufficient Heating; Insufficient Heating
A REPORT WAS RECEIVED THAT THE RETURNED ELECTRODE REVEALED THE RETURNED ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7889509 ↗MalfunctionAug 7, 2018Material Separation; Material Separation
DEVICE ANALYSIS PERFORMED ON THE ELECTRODES REVEALED THAT THE SHAFTS OF ALL THIRTEEN ELECTRODES WERE FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFTS WERE NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TESTS COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7758016 ↗MalfunctionAug 1, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE WHICH REVEALED THE SHAFT OF THE ELECTRODE TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7740252 ↗MalfunctionAug 1, 2018Fracture; Fracture
THE VISUAL INSPECTION ON THE RETURNED ELECTRODE REVEALED THAT THE ELECTRODE SHAFT WAS BROKEN RIGHT AT THE HUB. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE BROKEN ELECTRODE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7739898 ↗MalfunctionAug 1, 2018Material Separation; Material Separation
THE DEVICE ANALYSIS PERFORMED ON THE TWO RETURNED ELECTRODE REVEALED THAT THE SHAFTS OF THE ELECTRODES WERE FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE FUNCTIONAL TESTS COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7739793 ↗
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 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
- 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 14, 2026 · each report above links to its original FDA record
- 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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