AVANOS CRKA-17-75-2Recalls & reported problems
Avanos Medical, Inc. · CRKA-17-75-2 AVNS,RF,RFQKIT,,-,1 · Class 2
Data updated Oct 18, 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 00193493479085), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2025Device Handling Problem; Device Handling Problem
IT WAS REPORTED, "PHYSICIAN HAD FELLOW HOLD THE CANNULA IN PLACE WITH A KELLY CLAMP BECAUSE THE (B)(6) WAS TOO SHORT TO REACH THE TARGET AREA IN THE SHOULDER. THE CLAMP WAS PLACED ON THE COPPER PART OF THE CANNULA. WE HAD ALREADY DONE ALL 4 POSTERIOR LESIONS AND WAS DOING THE ANTERIOR LESION. I WAS FOCUSED ON THE GENERATOR BECAUSE THE TEMPERATURE WASN'T GOING UP BUT THE IMPEDANCE LOOKED GOOD. WE HEARD AN AUDIBLE POP AND TURNED THE MACHINE OFF. THE DOCTORS LOOKED AT THE SKIN AROUND THE PROBE ENTRY AND DIDN'T SEE ANYTHING ABNORMAL, AND I WAS INSTRUCTED TO RESUME LESIONING. AFTER A FEW SECONDS THE FELLOW DREW DR. VILLALOBO'S ATTENTION TO THE PATIENT'S SHOULDER. THE FELLOW WAS HOLDING THE KELLY CLAMP AND ALLOWED THE CLAMP TO REST ON THE PATIENT'S SHOULDER, AND THE HEAT SEEMS TO HAVE TRANSFERRED TO THAT AREA AND CAUSED A SKIN BURN. THE PATIENT WAS TREATED AND SENT HOME. MD WILL FOLLOW-UP. (B)(6) NURSE CALLED CLINICAL SPECIALIST FOR ADDITIONAL FOR THIS INCIDENT. SHE STATES THAT THE PHYSICIAN THOUGHT THE BURN WAS A 3RD DEGREE BURN AND IT WAS TREATED, PATIENT WAS GIVEN OINTMENT. OVERALL CONSENSUS OF THE EVENT IS THOUGHT TO BE RELATED TO THE PLACEMENT OF THE KELLY CLAMP ON THE PROBE WHICH D
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 23716943 ↗
Other Probe, radiofrequency lesion devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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