NeoLead® StandardRecalls & reported problems
Neotech Products LLC · NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph electrode (per FDA regulation# 870.2360 ) is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. · Class 2
- 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 10812594011051), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unable to Obtain Readings” (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.
Most reported problems
Device problems
- Unable to Obtain Readings1
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.
MalfunctionJun 28, 2018Unable to Obtain Readings; Unable to Obtain Readings
CUSTOMER REPORTED THAT SOME OF THE NEO LEADS N301 WERE NOT PICKING UP ANY READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7648463 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.