Neuroguard S41-938Recalls & reported problems
Technomed Engineering B.V. · Disposable Subdermal Needle Electrode, single, Stainless Steel, 4 x 6 colors, 2.5m PVC single wire · Class 2
- 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 08718375863312), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2026Insufficient Device Problem Information
TECHNOMED RECEIVED A COMPLAINT VIA MPOWER/CADWELL WITH A REPORTED INCIDENT THAT RESULTED IN A PATIENT BURN INVOLVING A NEUROGUARD ELECTRODE (REF#: S41-938; LOT#: 102884). THE NEUROGUARD ELECTRODE USED AND THE CADWELL EQUIPMENT WERE OWNED BY (B)(6). SMALL BURN NOTES AT ERBS POINT RECORDING SITE IN LEFT CLAVICLE.
Patient problems: Burn(s)
MAUDE report 24935949 ↗
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- Technomed Europe TE/S50715-002Technomed Engineering B.V. · Electrode, Needle1 recall0 reports
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- Rhythmlink® RLSND121-2.5Rhythmlink International, LLC · Electrode, Needle5 reports
- NA 8227411Medtronic Xomed, Inc. · ELECTRODE, NEEDLE4 reports
- Rhythmlink® RLSP503Rhythmlink International, LLC · Electrode, Needle3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.