NA CSK-TC10-3MRecalls & reported problems
Boston Scientific Neuromodulation Corporation · CSK 10cm TC Electrode with 3m Cable · 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 10cm TC electrode is a reusable radiofrequency lesioning electrode with a 3m cable. The 34 reports mostly describe the electrode shaft breaking or pulling away from the hub, along with leaking, discoloration, and heating that fell short of expected levels; none involved death or injury. One open recall, started 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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00813250011524), received between Jun 1, 2017 and Jun 12, 2019 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Break” (13 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.
Recalls naming this device
- Apr 29, 2026Class IIOpen, 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
- Break13
- Material Separation11
- Leak/Splash6
- Defective Device2
- Insufficient Heating2
- Material Discolored2
- Contamination /Decontamination Problem1
- Corroded1
Patient problems
- No Known Impact Or Consequence To Patient33
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2019Insufficient Heating; Insufficient Heating
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE 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 Known Impact Or Consequence To Patient
MAUDE report 8693778 ↗MalfunctionSep 18, 2018Insufficient Heating; Insufficient Heating
THE DEVICE ANALYSIS ON THE RETURNED ELECTRODE REVEALED SEPARATION OF THE SHAFT FROM THE HUB. THE ROOT CAUSE IS EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7885411 ↗MalfunctionAug 13, 2018Material Separation; Material Separation
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODES FOUND THAT THE SHAFT OF THE ELECTRODE WAS SEPARATED FROM THE HUB AND NOT RETURNED FOR ANALYSIS. THE DAMAGE WAS DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7778146 ↗MalfunctionAug 1, 2018Fracture; Fracture
THE VISUAL INSPECTION ON THE RETURNED ELECTRODE REVEALED THAT ELECTRODE SHAFT WAS BROKEN RIGHT AT THE HUB. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO BROKEN ELECTRODE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7739442 ↗MalfunctionJul 30, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT OF THE ELECTRODE WAS FOUND 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 7733140 ↗MalfunctionJul 17, 2018Defective Device; Defective Device
A REPORT WAS RECEIVED THAT THE ELECTRODE WAS BROKEN AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7696760 ↗MalfunctionJul 17, 2018Defective Device; Defective Device
A REPORT WAS RECEIVED THAT THE ELECTRODE WAS BROKEN AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7696141 ↗MalfunctionJun 28, 2018Material Separation; Material Separation
DEVICE ANALYSIS ON THE RETURNED ELECTRODE REVEALED THAT THE SHAFT OF THE ELECTRODE WAS FOUND 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 7647936 ↗MalfunctionJun 28, 2018Material Separation; Material Separation
DEVICE ANALYSIS ON THE RETURNED ELECTRODE REVEALED THAT THE ELECTRODE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB. THE ROOT CAUSE OF THE FAILURE IS EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7647692 ↗MalfunctionMay 30, 2018Break; Break
THE DEVICE ANALYSIS 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 HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7555526 ↗MalfunctionMay 21, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE TWO RETURNED ELECTRODES FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFTS WERE NOT RETURNED FOR ANALYSES. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7529594 ↗MalfunctionApr 9, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE AND FOUND THAT THE ELECTRODE SHAFT WAS SEPARATED FROM THE HUB AND NOT RETURNED FOR ANALYSIS. ROOT CAUSE OF THE FAILURE IS EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7406973 ↗MalfunctionMar 27, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE TWO RETURNED ELECTRODES FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUBS DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFTS WERE NOT RETURNED FOR ANALYSIS AND THEREFORE FUNCTIONAL TESTS COULD NOT BE PERFORMED ON THE SEPARATED SHAFTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7374893 ↗MalfunctionJan 24, 2018Material Separation; Material Separation
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT WAS SEPARATED FROM THE HUB. ROOT CAUSE OF THE FAILURE IS EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7215542 ↗MalfunctionNov 30, 2017Material Separation; Material Separation
DEVICE ANALYSIS OF THE RETURNED ELECTRODE REVEALED THAT THE SHAFT WAS SEPARATED FROM THE HUB AND NOT RETURNED FOR ANALYSIS. ROOT CAUSE OF THE FAILURE IS EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7073015 ↗MalfunctionOct 16, 2017Break; Break
THE RETURNED ELECTRODE WAS ANALYZED AND CONFIRMED THE ELECTRODE SHAFT WAS BROKEN OFF AT THE HUB DUE TO EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6952093 ↗MalfunctionOct 5, 2017Leak/Splash; Leak/Splash
DEVICE ANALYSIS ON THE RETURNED ELECTRODE REVEALED TRACES OF POTTING EPOXY ON THE HUB. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6917633 ↗MalfunctionOct 5, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem
THE DEVICE ANALYSIS FOUND THAT THE EPOXY HAS CHIP OUT AND DISCOLORATION. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6915472 ↗MalfunctionOct 3, 2017Break; Break
THE DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE SHOWED THAT THE SHAFT WAS BROKEN OFF AT THE HUB DUE TO EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6912325 ↗MalfunctionOct 2, 2017Break; Break
THE RETURNED ELECTRODE WAS ANALYZED AND CONFIRMED THE ELECTRODE SHAFT WAS BROKEN OFF AT THE HUB, DUE TO EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6908012 ↗MalfunctionOct 2, 2017Break; Break
THE DEVICE ANALYSIS ON THE THREE ELECTRODES CONFIRMED THE SHAFTS WERE BROKEN OFF AT THE HUB, DUE TO EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6907899 ↗MalfunctionSep 29, 2017Leak/Splash; Leak/Splash
THE RETURNED ELECTRODE WAS ANALYZED AND VISUAL INSPECTION REVEALED TRACES OF POTTING EPOXY ON THE HUB. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904969 ↗MalfunctionSep 29, 2017Leak/Splash; Leak/Splash
THE RETURNED ELECTRODE WAS ANALYZED AND VISUAL INSPECTION REVEALED TRACES OF POTTING EPOXY ON THE HUB. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904514 ↗MalfunctionSep 28, 2017Leak/Splash; Leak/Splash
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE FOUND TRACES OF POTTING EPOXY ON THE HUB. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6902866 ↗MalfunctionSep 27, 2017Break; Material Separation; Break; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON A RETURNED ELECTRODE AND FOUND THAT THE SHAFT WAS BROKEN OFF AT THE HUB DUE TO EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6899053 ↗
Other GENERATOR, LESION, RADIOFREQUENCY devices
- NT2000iX™ RFG-NT-2000St. Jude Medical, Inc. · GENERATOR, LESION, RADIOFREQUENCY2 recalls310 reports
- 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
- IonicRF™ RFG-IONICSt. Jude Medical, Inc. · Generator, lesion, radiofrequency105 reports
- NA TCN-5Boston Scientific Neuromodulation Corporation · GENERATOR, LESION, RADIOFREQUENCY2 recalls1 report
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page