BlueSensor VLECG Electrodes VL-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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480022250), received between Jul 30, 2025 and Jul 30, 2025 — classified as 1 injury.
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
- Skin Tears2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
OtherJul 30, 2025Product Quality Problem; Product Quality Problem
TWO PATIENTS WERE INVOLVED AND EXPERIENCED RIPPING OF SKIN UPON REMOVAL OF THE BLUE SENSOR VL ELECTRODES. THE PATIENTS WERE PROVIDED WITH ADDITIONAL CARE.
Patient problems: Skin Tears
MAUDE report 22666564 ↗InjuryJul 30, 2025Product Quality Problem; Product Quality Problem
TWO PATIENTS WERE INVOLVED AND EXPERIENCED RIPPING OF SKIN UPON REMOVAL OF THE BLUE SENSOR VL ELECTRODES. THE PATIENTS WERE PROVIDED WITH ADDITIONAL CARE.
Patient problems: Skin Tears
MAUDE report 22663569 ↗
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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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