Halyard 44202Recalls & reported problems
Avanos Medical, Inc. · Coolief* Cooled Radiofrequency Kit · Class 2
- 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 10680651442021), received between Nov 21, 2019 and Nov 21, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PHYSICIAN PERFORMED MOTOR TESTING AT THE FEMORAL AND OBTURATOR TARGETS AND RECEIVED A NEGATIVE MOTOR RESPONSE PRIOR TO LESIONING. THE PATIENT WAS COMPLAINING ABOUT LOSS OF FUNCTION AFTER THE PROCEDURE. SEVERAL MONTHS POST PROCEDURE THE "PATIENT REPORTED IMPROVED FUNCTIONALITY. ADDITIONAL INFORMATION RECEIVED 19-NOV-2019 STATED THE PATIENT UNDERWENT BILATERAL HIP PROCEDURES. THE PATIENT HAD THE LEFT HIP TREATED FIRST WITH 100% PAIN RELIEF (DATE UNKNOWN.) THEN THE PATIENT HAD THE RIGHT HIP DONE ON (B)(6) 2019. SUBSEQUENT ISSUES WERE WITH THE RIGHT KNEE. FOUR WEEKS POST-PROCEDURE, THE PATIENT WAS FOUND TO HAVE "NO EXTENSION OR FLEXION" AND COMPLAINED OF LIMITED FUNCTION OF RIGHT KNEE. TWO EMG'S WERE PERFORMED DURING FOLLOW-UP ASSESSMENTS AND THE PATIENT WAS GIVEN A KNEE BRACE.
Patient problems: Nerve Damage
MAUDE report 9357163 ↗
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
- Intracept RLV 0075Relievant Medsystems, Inc. · Probe, Radiofrequency Lesion1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.