NA CSK-TC5Recalls & reported problems
Boston Scientific Neuromodulation Corporation · CSK TC Electrode, 5cm · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813250010091), received between Jan 26, 2018 and Aug 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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 Separation2
- Break1
- Structural Problem1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 19966839 ↗MalfunctionApr 30, 2018Break; Material Separation; Break; Material Separation
THE DEVICE ANALYSIS PERFORMED ON THE ELECTRODE (CSK-T5, LOT M229) REVEALED THAT A PORTION OF THE SHAFT OF THE ELECTRODE WAS BROKEN OFF DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE DEVICE ANALYSIS PERFORMED ON FIVE ELECTRODES (CSK-TC10, ALL WITH LOT K239) FOUND THAT THE ELECTRODES WERE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE DEVICE ANALYSIS PERFORMED ON THE ELECTRODE (CSK-10TC, LOT K509) REVEALED THAT THE ELECTRODE WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7474156 ↗MalfunctionJan 26, 2018Material Separation; Material Separation
A REPORT WAS RECEIVED THAT THE ELECTRODE FELL OUT FROM ITS FIXING HEAD WHILE TAKING OFF THE GUIDE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7222181 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.