COOLIEF* Cooled Radiofrequency Pain Management Generator 42297Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651422979), received between Apr 3, 2024 and Sep 1, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Excessive Heating” (1 report).

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 18, 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.

• MalfunctionSep 1, 2026Sparking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545024 ↗
• InjuryApr 3, 2024Excessive Heating; Excessive Heating

  IT WAS REPORTED THE "MACHINE WAS NOT ABLE TO ACHIEVE BURNING TEMPERATURE, WITH IMPEDANCE RISING FROM 500 TO 2200 OHMS PRIOR TO SELF-TERMINATING AFTER APPROXIMATELY 40 SEC ATTEMPTED FURTHER 2 ATTEMPTS AT RF AT ABOVE SETTINGS WITH SAME ISSUE PULLED BACK BLANKET TO ENSURE DIATHERMY PAD WAS WELL ADHERED TO THE LEG IN CASE THAT WAS THE ISSUE AND NOTED CHARRING. IMMEDIATELY TURNED OFF THE MACHINE AND INSTRUCTED [THE PHYSICIAN] TO TERMINATE THE PROCEDURE." THE PATIENT'S INJURIES NOTED TWO POINTS OF BURN ON THE CORRESPONDING TO DIAGONAL POINTS OF THE DIATHERMY PAD - TWO BURNS ON THIGH WITH CHARRING. "UNCLEAR IF ARCED OVER SKIN OR THROUGH MUSCLE. MEDICAL TREATMENT WAS PROVIDED SECONDARY TO BURNS TO THIGHS. THE CLINICIANS "IMPRESSION IS THAT THERE WAS POOR CONTACT OF THE SKIN ADHESIVE TO THE SKIN DUE TO INTERFERENCE FROM HAIR." MEDICAL TREATMENT "WAS PROVIDED SECONDARY TO BURNS TO THIGHS."

  Patient problems: Burn(s)

  MAUDE report 19037430 ↗