Continuous ECG Platform VV330Recalls & reported problems
Vivalnk, Inc. · VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00865064000157), received between Jul 21, 2026 and Jul 21, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Missing Information” (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.
Reports received per month
Most reported problems
Device problems
- Missing Information1
Patient problems
- Arrhythmia1
- Burn(s)1
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026Missing Information
THE PATIENT WAS PLUGGING A NON-VIVALINK EXTENSION CORD INTO THE ELECTRICAL PLUG, AT THAT MOMENT A SPARK FLEW OUT, AND THE ELECTRIC CURRENT RAN THROUGH HER ENTIRE BODY. THERE IS A SMALL BURN ON HER LEFT PALM, WHERE SHE HELD THE WOODEN CLOSET. AFTER THE ELECTRICAL DISCHARGE CURRENT, SHE EXPERIENCED SUBJECTIVE ARRHYTHMIA, HEADACHE, ALSO MEASURED HYPERTENSION UP TO 190/100 MMHG, TOOK TENSIOMIN 12.5 MG TABLETS. ECG WITHOUT ACUTE ISCHEMIC CHANGES. THE PATIENT COMPLAINS THAT THE INSTRUCTIONS FOR USE DO NOT MENTION THE NEED TO BE CAREFUL NOT ONLY WITH WATER, BUT ALSO WITH ELECTRICITY. THE PATIENT BELIEVES THAT THE LONG-TERM EKG RECORDER SHE WAS WEARING AT THE TIME OF THE INCIDENT CONTRIBUTED TO THE ELECTRIC SHOCK.
Patient problems: Arrhythmia; Burn(s); High Blood Pressure/ Hypertension
MAUDE report 25894431 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.