NA CSK-TC15Recalls & reported problems
Boston Scientific Neuromodulation Corporation · CSK TC Electrode, 15cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00813250010114), received between Sep 19, 2017 and Feb 23, 2024 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Material Separation” (7 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. How this data works · Data updated Oct 13, 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 · FDA record ↗
Most reported problems
Device problems
- Material Separation7
- Break5
- Insufficient Heating4
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Device Issue1
- Leak/Splash1
- Structural Problem1
Patient problems
- No Known Impact Or Consequence To Patient16
- No Consequences Or Impact To Patient3
- No Patient Involvement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2024Structural Problem; Structural Problem
IT WAS REPORTED THAT THE ELECTRODE HAD A BROKEN WIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18773850 ↗MalfunctionJun 12, 2019Defective Device; Defective Device
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 Patient Involvement
MAUDE report 8692499 ↗MalfunctionNov 15, 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. IT WAS CONFIRMED THAT THE ELECTRODE WAS NOT REACHING TEMPERATURE. THE PROBABLE CAUSE IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. THE SHAFT WAS LIKELY DAMAGED BY THE USER PRESSING TOO HARD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8075819 ↗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 8074562 ↗MalfunctionNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 8053244 ↗MalfunctionOct 16, 2018Insufficient Heating; Adverse Event Without Identified Device or Use Problem; Insufficient Heating; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED THAT THE ELECTRODE SHAFT WAS SEPARATED FROM THE HUB AND NOT RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THE FAILURE WAS FOUND TO BE EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT, WHICH LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.
Patient problems: No Patient Involvement
MAUDE report 7971869 ↗MalfunctionSep 24, 2018Insufficient Heating; Insufficient Heating
DEVICE ANALYSIS ON THE RETURNED ELECTRODE REVEALED THAT THE SHAFT OF THE ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7901935 ↗MalfunctionAug 6, 2018Defective Device; Defective Device
A REPORT WAS RECEIVED THAT THE ELECTRODE WAS BROKE AT THE HUB DURING A PROCEDURE. THE PATIENT WAS NOT HARMED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT ELECTRODE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7753184 ↗MalfunctionJun 28, 2018Break; Break
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 7649139 ↗MalfunctionJun 12, 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 7591162 ↗MalfunctionJun 7, 2018Material Separation; Material Separation
THE DEVICE ANALYSIS PERFORMED 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 7578167 ↗MalfunctionApr 30, 2018Break; Break
A REPORT WAS RECEIVED THAT THE ELECTRODE WAS BROKEN IN TWO PIECES AND THAT THE BURNING PART OF THE ELECTRODE WAS DISCONNECTED FROM THE CORD.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7473900 ↗MalfunctionMar 20, 2018Break; Break
A REPORT WAS RECEIVED THAT THE ELECTRODES WERE BROKEN AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7356113 ↗MalfunctionMar 12, 2018Material Separation; Material Separation
DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7330977 ↗MalfunctionFeb 27, 2018Break; Break
A REPORT WAS RECEIVED THAT ONE CSK-TC15 ELECTRODE AND ONE CSK-TC10 ELECTRODE WERE BROKEN AT THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7299900 ↗MalfunctionFeb 27, 2018Material Separation; Material Separation
A REPORT WAS RECEIVED THAT AN ELECTRODE HAD A WIRE COME OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7299763 ↗MalfunctionFeb 20, 2018Break; Break
A REPORT WAS RECEIVED THAT THE WIRE ELECTRODE WAS BROKEN OFF FROM THE HUB OF THE CSK-TC15, AND THAT THE PLASTIC COVERING AT THE HUB WAS CRACKED ON THE CSK-TC10 ELECTRODE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7283803 ↗MalfunctionFeb 5, 2018Material Separation; Material Separation
DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT WAS 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 7243026 ↗MalfunctionJan 17, 2018Material Separation; Material Separation
DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7201708 ↗MalfunctionNov 14, 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 7028037 ↗MalfunctionSep 28, 2017Leak/Splash; Leak/Splash
DEVICE ANALYSIS OF THE RETURNED ELECTRODES INDICATED THAT TRACES OF POTTING EPOXY WERE FOUND ON THE HUBS. THE EPOXY LEAKED THROUGH THE SHAFT OPENINGS IN IT'S LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6901675 ↗MalfunctionSep 19, 2017Device Issue; Device Issue
DEVICE EVALUATION WAS PERFORMED ON THE RETURNED ELECTRODE AND FOUND TRACES OF POTTING EPOXY ON THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6876364 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.