NA CSK-TC15-3MRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00813250011548), received between Aug 15, 2017 and May 23, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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.

Recalls naming this device

1. 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2019Defective Device; Defective Device

  DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT 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 8636428 ↗
• MalfunctionAug 2, 2018Material Discolored; Material Separation; Material Discolored; Material Separation

  DEVICE ANALYSIS ON THE RETURNED ELECTRODE (L741) 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. IN ADDITION A SECOND ELECTRODE (21816) WAS ANALYZED AND A VISUAL INSPECTION REVEALED A DISCOLORED EPOXY AND A CHIP OUT. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, THE EPOXY BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744571 ↗
• MalfunctionMay 30, 2018Material Separation; Material Separation

  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 LED TO THE COMPLETE SEPARATION OF THE SHAFT FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555670 ↗
• MalfunctionMay 10, 2018Material Separation; Material Separation

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODE FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502736 ↗
• MalfunctionOct 18, 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 6960020 ↗
• MalfunctionOct 18, 2017Break; Break

  A REPORT WAS RECEIVED THAT AN ELECTRODE HAS A BROKEN WIRE FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6959987 ↗
• MalfunctionAug 15, 2017Material Erosion; Material Erosion

  DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE AND FOUND THAT SOME ADHESIVE HAD MOVED OUT OF THE HUB HOLE AROUND THE ELECTRODE SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796057 ↗