AVANOS CRK-17-150-4Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193493442027), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K053082); they may or may not involve this specific model.
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
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE "COATING/INSULATION ON THE INTRODUCER PEELED BACK MAKING IT DIFFICULT TO INSERT. THE DOCTOR DID NOT REALIZE THE COATING INSULATION WAS PEELED BACK UNTIL AFTER THE PROCEDURE." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 15-JULY-2021 INDICATED "THERE WAS NO PATIENT INJURY AND THAT THEY WERE ABLE TO USE THE KIT. IT WAS NOT REPLACED. IT WAS NOTICED AFTER THE PROCEDURE." ADDITIONAL INFORMATION RECEIVED 22-JULY-2021 CONFIRMED "PT [PATIENT] HAD NO ADVERSE REACTION/EFFECTS TO THIS INCIDENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12255869 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053082. One submission often covers many models, so check the product and lot details in each record.
- Z-2391-2016 · Jun 16, 2016 · TerminatedCoolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
- Z-1755-2010 · May 12, 2010 · TerminatedThe Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalo
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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