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AVANOS 46938Recalls & reported problems

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

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 00193493469383), received between Jul 9, 2020 and Jul 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Peeled/Delaminated1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJul 9, 2020Peeled/Delaminated; Peeled/Delaminated

    IT WAS REPORTED THAT THE CASE WAS ABORTED DUE TO HIGH IMPEDANCE ERROR ON THE PMG [PAIN MANAGEMENT GENERATOR] THAT COULDN'T BE RESOLVED WITH TROUBLESHOOTING. WHEN REMOVING CANNULA FROM PATIENT'S LEFT KNEE, IT WAS FOUND THAT THE INSULATION ON THE INTRODUCER HAD SLIPPED DOWN THE SHAFT, COVERING THE TIP OF THE PROBE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10254773 ↗

Other PROBE, RADIOFREQUENCY LESION devices

All PROBE, RADIOFREQUENCY LESION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.