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CONCEPT HEATWAVE CS-024Recalls & reported problems

Conmed Corporation · 60MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5 · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854021866), received between Apr 12, 2017 and Apr 12, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

1 other recall cover devices cleared under the same FDA submission (K991830); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 12, 2017Material Fragmentation; Material Fragmentation

    THE USER FACILITY REPORTED THAT DURING USE OF THE 60MMX2.3MM DIAMETER CONCEPT HEATWAVE ELECTRODE IN A WRIST ARTHROSCOPY PROCEDURE, THE "INSULATION ON THE TIP OF THE ELECTRODE BROKE AWAY". AS REPORTED, THE BREAKAGE OCCURRED DURING COAGULATION. THE BROKEN INSULATION PIECE WAS SAFELY RETRIEVED WITH NO PROBLEMS AND NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS OTHERWISE COMPLETED AS PLANNED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY. DESPITE THE GOOD FAITH EFFORT, NO PATIENT DEMOGRAPHIC INFORMATION COULD BE OBTAINED FROM THE USER FACILITY. THIS REPORT IS FILED ON THE BASIC OF POTENTIAL FOR PATIENT INJURY WITH RECURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6487020 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991830. One submission often covers many models, so check the product and lot details in each record.

  • Z-0085-2017 · Aug 29, 2016 · Terminated
    CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulati

Other Electrode, electrosurgical devices

All Electrode, electrosurgical devices →

Sources and updates

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