NeoLead RadioLucent 812594010293Recalls & reported problems
Neotech Products LLC · Electrode (Each) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812594010293), received between May 23, 2018 and May 26, 2023 — classified as 3 injuries, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Lead(s), Burn(s) From3
- Skin Erosion1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CIRCULAR RASH WITH BLISTERS WAS NOTICED ON PATIENT'S SKIN.
Patient problems: Lead(s), Burn(s) From
MAUDE report 7542305 ↗InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CIRCULAR RASH/BURN WITH BLISTERS WAS NOTICED ON PATIENT'S SKIN.
Patient problems: Lead(s), Burn(s) From
MAUDE report 7541624 ↗InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CIRCULAR RASH/BURN WITH WHITE PAPULES/BLISTERS WAS NOTICED ON PATIENT'S SKIN.
Patient problems: Lead(s), Burn(s) From
MAUDE report 7539155 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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