AVANOS CRKA-17-50-4Recalls & reported problems
Avanos Medical, Inc. · CRKA-17-50-4 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493478811), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "AN INFECTION OCCURRED IN A PATIENT WHO WAS TREATED WITH COOLIEF." THE INFECTION SITE WAS AT THE MEDIAL ASPECT ABOVE THE PATIENT'S RIGHT KNEE. THE COOLIEF TREATMENT DATE WAS (B)(6) 2025. THE PATIENT BEGAN EXPERIENCING PAIN ON (B)(6) 2026. AT THE VISIT ON (B)(6) 2026, THE CONDITION WAS DIAGNOSED AS AN INFECTION. IT IS UNCLEAR WHETHER THE SYMPTOMS ARE DUE TO A BACTERIAL INFECTION OR AN EXACERBATION OF INFLAMMATION CAUSED BY THE ABLATION PROCEDURE. HOWEVER, AS THE SYMPTOMS OCCURRED AT THE TREATMENT SITE, IT IS PRESUMED THAT THE CONDITION WAS DIAGNOSED AS AN INFECTION. ADDITIONAL INFORMATION RECEIVED 03-MAR-2026 STATING TREATMENT FOR THE INFECTION INCLUDED THE ADMINISTRATION OF INTRAVENOUS (IV) MEDICATION THERAPY. INFUSION THERAPY WAS ADMINISTERED. THE TREATMENT IS ONGOING. THE CURRENT CONDITION IS UNDER CONTINUED FOLLOW-UP. NO MEDICAL INTERVENTION OTHER THAN IV INFUSION THERAPY WAS REQUIRED.
Patient problems: Bacterial Infection
MAUDE report 24520802 ↗
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- Intracept RLV 0055Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall30 reports
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- 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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