Neurosign V4 3601-00-TERecalls & reported problems
Technomed Engineering B.V. · Disposable Bipolar Probe 2 x 100mm x 0.75mm electrodes; 1.9m wire with DIN42802 connectors · Class 2
All models of Neurosign V4 (3)
Data updated Oct 18, 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 08718375864982), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Analyze Signal” (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.
Most reported problems
Device problems
- Failure to Analyze Signal1
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.
MalfunctionNov 27, 2019Failure to Analyze Signal; Failure to Analyze Signal
DURING PAROTIDECTOMY SURGERY, SURGEONS DETECTED A NERVE THEMSELVES WHICH WAS NOT PICKED UP BY THE DEVICE (PROBE) USED. USING ANOTHER PROBE, THE NERVE WAS DETECTED. SURGEONS CONCLUDED THE DEVICE MAY HAVE MALFUNCTIONED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9381013 ↗
Other Electrode, Needle devices
- Technomed Europe TE/S50715-003Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50715-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Technomed Europe TE/S50725-002-CTechnomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Neurosign V4 5888-00Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
- Rhythmlink® RLSND121-2.5Rhythmlink International, LLC · Electrode, Needle5 reports
- NA 8227411Medtronic Xomed, Inc. · ELECTRODE, NEEDLE4 reports
- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 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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