BlueSensor NECG Electrodes N-00-S/25Recalls & reported problems
Ambu A/S · ECG electrodes · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480022106), received between Jul 2, 2025 and Jul 3, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Product Quality Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem2
Patient problems
- Localized Skin Lesion2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2025Product Quality Problem; Product Quality Problem
THE FAILURE WAS REPORTED FROM PHONIATRICS AND PEDIATRIC AUDIOLOGY DEPARTMENT. THE CUSTOMER STATED THAT THE ELECTRODES CAN ONLY BE PAINFULLY REMOVED FROM THE SKIN. THE ADHESIVE SEEMS TOO STRONG, AS THREE CHILDREN HAVE DEVELOPED OPEN SKIN LESIONS.
Patient problems: Localized Skin Lesion
MAUDE report 22393752 ↗InjuryJul 2, 2025Product Quality Problem; Product Quality Problem
THE FAILURE WAS REPORTED FROM PHONIATRICS AND PEDIATRIC AUDIOLOGY DEPARTMENT. THE CUSTOMER STATED THAT THE ELECTRODES CAN ONLY BE PAINFULLY REMOVED FROM THE SKIN. THE ADHESIVE SEEMS TOO STRONG, AS THREE CHILDREN HAVE DEVELOPED OPEN SKIN LESIONS.
Patient problems: Localized Skin Lesion
MAUDE report 22384219 ↗
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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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