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AVANOS CRK-17-75-4Recalls & reported problems

Avanos Medical, Inc. · COOLIEF* Cooled Radiofrequency Probe Kit · Class 2

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493393213), received between Dec 1, 2022 and Dec 1, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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 16, 2026.

Most reported problems

Device problems

  • Display or Visual Feedback Problem1

Patient problems

  • Burn(s)1
  • Pain1

Recent adverse event reports

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

  • InjuryDec 1, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

    IT WAS REPORTED THAT 'PATIENT IS ADMITTED FOR RADIOFREQUENCY OF GENICULATE NERVES, OF THE RIGHT KNEE, A DISPERSIVE ELECTRODE IS PLACED IN THE LEFT LOWER LIMB, IN THE GASTRONEMIA. THE PROCEDURE BEGINS, ACCOMPANIED BY THE DOCTOR; ABLATIONS OF THE SUPERIOR LATERAL GENICULATE NERVE AND MEDIAL SUPERIOR GENICULATE NERVE ARE PERFORMED WITH A TEMPERATURE OF 60 DEGREES WITH A DURATION OF 02 MINUTES-30 SECONDS, OF WHICH NO INCREASE OR DECREASE IN TEMPERATURE [NOR] IMPEDANCE WAS OBSERVED. [IMPEDANCE WAS] BETWEEN 200 AND 300 [OHMS]. WHEN THE ABLATION OF THE INFERIOR MEDIAL GENICULATE NERVE BEGINS, A BURN IS OBSERVED; THE PHYSICIAN IMMEDIATELY STOPS THE ABLATION, WHICH TOOK APPROXIMATELY 30 SECONDS, AND STOPS THE PROCEDURE; NO INCREASE OR DECREASE IN TEMPERATURE WAS OBSERVED DURING THE 30 SECONDS, [THE] IMPEDANCE [WAS] BETWEEN 200 AND 300 [OHMS]. IN THE POSTOPERATIVE PERIOD, THE DOCTOR PERFORMS AN ASSESSMENT AGAIN, WHERE HE OBSERVES, APART FROM THE INFERIOR MEDIAL GENICULATE NERVE, A SMALL BURN ON THE SUPERIOR LATERAL GENICULATE NERVE. [THE DOCTOR] INDICATES THAT A DUODERM PATCH BE PLACED ON THE AFFECTED AREA.' THE PATIENT RECEIVED INTRAVENOUS ANALGESIC ENANTYUM AND WAS REPORTED TO BE FINE AND

    Patient problems: Burn(s); Pain

    MAUDE report 15894976 ↗

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Sources and updates

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