Halyard 98693Recalls & reported problems
Avanos Medical, Inc. · HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-22-100-Straight-Black-Black · 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 10680651986938), received between Jun 1, 2018 and Jun 1, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (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
- Smoking1
- Sparking1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2018Smoking; Sparking; Smoking; Sparking
IT WAS REPORTED THE "NEEDLE NEAR THE SKIN OF THE PATIENT SMOKED AND SPARKED" DURING USE OF THE PAIN GENERATOR. THE CLINICIANS WERE PERFORMING A 3-LEVEL LUMBAR, SINGLE PROBE CASE. AS SOON AS THE SMOKING AND SPARKING STARTED THE CLINICIANS STOPPED THE USE OF THE PAIN GENERATOR. WHEN RESTARTED, IT HAPPENED AGAIN, AND THE IMPEDANCE WAS HIGH. THE DEVICE WAS RESTARTED ONCE MORE AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE CLINICIANS PERFORMED A CERVICAL CASE LATER AND HAD NO ISSUE NOR A REPEAT OF THE INCIDENT. THE CLINICIANS NOTICED THE IMPEDANCE WAS HIGH AND REACHED UP TO 942 OHMS (SHUT OFF THE GENERATOR OCCURS AT 1000 OHMS). ADDITIONAL INFORMATION RECEIVED STATED 08-MAY-2018 THIS EVENT IS IN REGARDS TO THE PROBE DEVICE. NO PATIENT INJURY OBSERVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561873 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page