NeuroPlus™ A10042-10Recalls & reported problems
Graphic Controls Acquisition Corp · Disposable Medical Electrodes 10 per pouch, 45 pouch per case 450 per case · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This NeuroPlus disposable skin electrode is a single-use pad used to attach sensors or leads to the skin. The 29 reports mostly describe skin irritation after use — redness, itching, burning, blisters, rash, and raw or weeping skin — and several patients say the patch stopped sticking;29 injuries were reported and no deaths. Reports rose sharply, from 5 in the prior12 months to 23 in the last12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 20813150020941), received between Jan 31, 2022 and Sep 16, 2026 — classified as 32 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem32
Patient problems
- Skin Inflammation/ Irritation30
- Blister12
- Itching Sensation9
- Rash9
- Burning Sensation8
- Erythema6
- Local Reaction1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Skin Inflammation/ Irritation
MAUDE report 50795167 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Skin Inflammation/ Irritation
MAUDE report 50619141 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50618882 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 50141000 ↗InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING SENSATION AND TENDERNESS. PATCH WOULD NOT STICK TO SKIN. PATIENT SOUGHT MEDICAL TREATMENT FROM A DERMATOLOGIST AND WAS PRESCRIBED MEDICATION. PATIENT REPORTED FOLLOWING THE RECOMMENDED SKIN PREPARATION STEPS.
Patient problems: Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 25856421 ↗InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF RED BUMPS, BLISTERS, AND BLEEDING/DISCHARGE. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS TREATED WITH OTC MEDICATION, AND SUBSEQUENTLY PRESCRIBED HYDRAZONE AND SULFATHIAZOLE ANTIBIOTIC POWDER. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION INSTRUCTIONS.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 25531773 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF RASH, BLISTERS/WELTS, AND RAWNESS WITH OPEN SKIN. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED A TOPICAL ANTI-INFLAMMATORY MEDICATION. THE PATIENT REPORTED FOLLOWING THE PROPER SKIN PREPARATION STEPS.
Patient problems: Blister; Rash; Skin Inflammation/ Irritation
MAUDE report 25123427 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING SENSATION, ITCHING, BLEEDING, DISCHARGE, OPEN SORES/SKIN/RAWNESS, AND OPEN SKIN/SCABBING. THE PATIENT SOUGHT MEDICAL TREATMENT FROM THEIR DOCTOR AND USED A PRESCRIPTION TOPICAL STEROID. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION.
Patient problems: Burning Sensation; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 25123393 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING (SENSATION), REDNESS, ITCHING, AND RAISED SKIN/BUMPS. THE PATIENT DID SEEK MEDICAL TREATMENT FROM THEIR DOCTOR AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION.
Patient problems: Burning Sensation; Erythema; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 25055660 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING SENSATION, ITCHING, BLEEDING/DISCHARGE, AND BLISTERS/WELTS. THE PATIENT SOUGHT MEDICAL TREATMENT AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING THE PROPER SKIN PREPARATION INSTRUCTIONS.
Patient problems: Blister; Burning Sensation; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 25031858 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF REDNESS, ITCHING, AND BLISTERS/WELTS. THE PATIENT SOUGHT MEDICAL TREATMENT FROM THEIR DOCTOR AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION.
Patient problems: Blister; Erythema; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 24903280 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF HIVES AND BLISTERS/WELTS. THE PATIENT DID SEEK MEDICAL ATTENTION FROM THEIR DOCTOR AND WAS ADVISED TO USE AN OTC MEDICATION. THE PATIENT DID NOT FOLLOW SKIN PREPARATION GUIDELINES.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 24778839 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING SENSATION, RASH, AND RAWNESS. THE PATIENT SOUGHT MEDICAL TREATMENT AND WAS PRESCRIBED TRIAMCINOLONE ACETONIDE (TOPICAL STEROID). THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION GUIDELINES.
Patient problems: Burning Sensation; Rash; Skin Inflammation/ Irritation
MAUDE report 24673439 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF OPEN SKIN. THE PATIENT SOUGHT MEDICAL TREATMENT AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION GUIDELINES.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24619068 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF OPEN SORES. THE PATIENT SOUGHT MEDICAL TREATMENT AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION GUIDELINES.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24558544 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING (SENSATION), REDNESS, OPEN SKIN, AND SCABBING. THE PATIENT DID SEEK MEDICAL TREATMENT AND WAS PRESCRIBED MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION.
Patient problems: Burning Sensation; Erythema; Skin Inflammation/ Irritation
MAUDE report 24428770 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKI IRRITATION IN THE FORM OF RASH AND BLISTERS/WELTS. THE PATIENT SOUGHT MEDICAL TREATMENT FROM THEIR DOCTOR AND WAS PRESCRIBED A TOPICAL STEROID. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION INSTRUCTIONS.
Patient problems: Blister; Rash; Skin Inflammation/ Irritation
MAUDE report 24334961 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF BURNING SENSATION, ITCHING, AND OPEN SORES. THE PATIENT SOUGHT MEDICAL TREATMENT FROM THEIR DOCTOR AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION GUIDELINES.
Patient problems: Burning Sensation; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 24306102 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF REDNESS, ITCHING, BLISTERS/WELTS, AND SCABBING. THE PATIENT DID SEEK MEDICAL TREATMENT AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION INSTRUCTIONS.
Patient problems: Blister; Erythema; Itching Sensation; Skin Inflammation/ Irritation
MAUDE report 24235298 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF RED BLISTERS WITH OPEN SKIN. THE PATIENT SOUGHT MEDICAL TREATMENT AND USED AN OTC MEDICATION (NEOSPORIN, VASELINE, OR AQUAPHOR). PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION GUIDELINES.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 24192933 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED SKIN IRRITATION IN THE FORM OF RED BUMPS WITH NO OPEN SKIN. PATIENT DID SEEK MEDICAL ATTENTION FROM A DERMATOLOGIST AND WAS PRESCRIBED A HYDROCORTISONE CREAM.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23991337 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT REPORTED ON (B)(6) 2025, THAT HE EXPERIENCED SKIN IRRITATION WHEN USING THE FLEXWIRE DEVICE. THE PATIENT REPORTED THE SKIN IRRITATION AS A BURNING (SENSATION), (SKIN) IRRITATION, ITCHING, AND RAISED SKIN. THE PATIENT REPORTED THAT HE DID SEEK MEDICAL TREATMENT AND SOUGHT THE USE OF PRESCRIBED MEDICATION TO TREAT THE SKIN IRRITATION. THE PATIENT REPORTED THE PRESCRIBED MEDICATION USED AS AN ORAL ANTIHISTAMINE. THE PATIENT REPORTED THAT HE DID NOT DISCONTINUE THE USE OF THE DEVICE. THE PATIENT REPORTED THAT HE DID FOLLOW THE SKIN PREP INSTRUCTIONS.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23872568 ↗InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED SKIN IRRITATION IN THE FORM OF BLISTERS/WELTS. THE PATIENT DID SEEK MEDICAL ATTENTION FROM THEIR DOCTOR AND USED AN OTC MEDICATION. THE PATIENT REPORTED FOLLOWING PROPER SKIN PREPARATION.
Patient problems: Blister; Skin Inflammation/ Irritation
MAUDE report 23843423 ↗InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION IN THE FORM OF GENERAL REDNESS, ITCHING, RASH, AND OPEN SORES. THE PATIENT DID SEEK MEDICAL TREATMENT AND WAS TREATED WITH AN OTC MEDICATION. THE PATIENT REPORTED THAT THEY DID NOT FOLLOW PROPER SKIN PREPARATION.
Patient problems: Itching Sensation; Rash; Skin Inflammation/ Irritation
MAUDE report 23803109 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED SKIN IRRITATION AS BROKEN OUT IN BLISTERS, RAISED RED BUMPS, AND A RASH. THE PATIENT DID SEEK MEDICAL TREATMENT AND THE USE OF AN OTC MEDICATION. THE PATIENT REPORTED THAT THEY DID NOT FOLLOW PROPER SKIN PREPARATION INSTRUCTIONS.
Patient problems: Blister; Rash; Skin Inflammation/ Irritation
MAUDE report 23542283 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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