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 ↗
Other Probe, radiofrequency lesion devices
- NA TCN-15Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls10 reports
- NA TCN-10-3MBoston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION2 recalls9 reports
- NA CSK-TC10Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall1 death58 reports
- NA CLASSICSt. Jude Medical, Inc. · PROBE, RADIOFREQUENCY LESION1 recall40 reports
- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
- Intracept RLV 0045Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall1 death23 reports
- Intracept RLV0065Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall14 reports
- NA CSK-TC5Boston Scientific Neuromodulation Corporation · PROBE, RADIOFREQUENCY LESION1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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