CONCEPT HEATWAVE CS-023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854021859), received between Mar 28, 2023 and May 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE CS-023 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5 WAS BEING USED ON APPROXIMATELY (B)(6) 2023 AND ¿WE ARE WAITING SOME INFO FROM THE CUSTOMER.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. AFTER FURTHER ASSESSMENT IT WAS FOUND ¿REPORT OF ELECTRODE DAMAGE: WHILE USING THE CONCEPT HEATWAVE ELECTRODE DURING A SIMPLE KNEE ARTHROSCOPY I NOTICED SEVERAL PLASTIC FRAGMENTS SCATTERED THROUGHOUT THE JOINT THAT DETACHED FROM THE ELECTRODE INSULATION (WITHOUT HAVING STRAINED AND WITHOUT HAVING USED OTHER TOOLS AT THE SAME TIME). I USED BOTH COAGULATION AND CUTTING.¿ ALL FRAGMENTATION WAS RETRIEVED AND THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931043 ↗
• MalfunctionMar 28, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED ON BEHALF OF THE DEVICE, CS-023, 130MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5 WAS USED DURING AN UNKNOWN PROCEDURE ON THE APPROXIMATE DATE OF (B)(6) 2023, WHEN IT WAS REPORTED, ¿DURING THE SURGERY ITEM IS BROKEN¿. AFTER FURTHER ASSESSMENT, IT WAS REPORTED THE DEVICE DID FRAGMENT, BUT IT WAS RETRIEVED WITH THE SHAVER SUCTION. THERE WAS NO PATIENT OR USER INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631279 ↗

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