EVO sEEG Electrode NSEEG3410-RFRecalls & reported problems
Neuroone Medical Technologies Corporation · 33.5mm x 10 Contact sEEG - RF Probe · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00856895008597), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Intracranial Hemorrhage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Malposition of Device
A report was received that on 04-Aug-2026 the implantation of sEEG depth electrodes in one patient went smoothly and all implanted electrodes were recording. A planned post-operative CT scan was performed of the implanted electrodes. During the CT it was noted that there was a bleed. The patient was taken back to the OR where they removed all of the electrodes, performed a craniotomy to remove a clot and used an aneurysm clip to stop the bleed.Post implant, the surgical team, reviewed the trajectories, data and surgical plan. It was confirmed that the implanted Anchor Bolts all matched the pre-planned trajectories, including trajectory 12. The CT scan showed that the tip of the electrode was off trajectory 12 by about 10 to 15 mm within 1 to 2 mm of entering the cranial space. The electrode tip entered the sylvian fissure and hit a branch of the Middle Cerebral Artery resulting in a large bleed.Post-operatively the physician said that he wasn't sure what caused the electrode deviation, and that it could have been caused by a number of things, such as "vascular structure, dura mater deflection, or an incomplete drill hole." The physician commented that he didn't think that it was ne
Patient problems: Intracranial Hemorrhage
MAUDE report 50487391 ↗
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- 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
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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