Halyard 40588Recalls & reported problems
Avanos Medical, Inc. · HALYARD* Multi-COOLED RF Kit · Class 2
Data updated Oct 13, 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 10680651405880), received between Dec 27, 2019 and Dec 27, 2019 — 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.
MalfunctionDec 27, 2019Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THE PHYSICIAN WAS INSERTING THE INTRODUCER INTO PATIENT'S LUMBAR AREA. THE PHYSICIAN REMOVED THE INTRODUCER, INSPECTED IT AND SET IT ASIDE. IT WAS NOTED THAT THE COPPER COLORED "WRAPPING" ON THE INTRODUCER HAD BEEN PUSHED UP EXPOSING MORE OF THE SILVER MATERIAL. THE PHYSICIAN HAD DIFFICULTY PUSHING THE NEEDLE THROUGH THE TISSUE AND THERE WAS AN ODD FEELING WHEN SHE TRIED TO ADVANCE IT AND THAT IS WHAT MADE HER REMOVE THE INTRODUCER FOR INSPECTION. THE PHYSICIAN WAS UNABLE TO USE IT FOR THE REST OF THE BILATERAL LUMBAR RADIO FREQUENCY ABLATION (RFA).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9528260 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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