LifeWatch Mobile Cardiac Telemetry 1 Lead Patch MCT 1L Patch-Universal Gateway-VerizonRecalls & reported problems
Lifewatch · ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850725007040), received between Jun 27, 2019 and May 14, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.
Most reported problems
Device problems
- Patient Device Interaction Problem3
- Insufficient Device Problem Information1
Patient problems
- Patient Problem/Medical Problem2
- Fainting1
- Skin Irritation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL DUE TO ALLERGIC REACTION/SKIN IRRITATION WHERE TREATMENT WAS PRESCRIBED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 10058343 ↗InjuryMar 26, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT COMMUNICATION OF CONSULTING A HEALTHCARE PROFESSIONAL DUE TO ALLERGIC REACTION/SKIN IRRITATION WHERE TREATMENT WAS PRESCRIBED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9885388 ↗InjuryJun 27, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
ON (B)(6) 2019, PATIENT NOTIFIED (B)(4), INC. OF SKIN IRRITATION/BLISTERS, INCLUDING ALLEGATION THAT PATIENT PASSED OUT FROM PAIN ASSOCIATED WITH EVENT. NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED ((B)(4)).
Patient problems: Fainting; Skin Irritation
MAUDE report 8739030 ↗
Other Transmitters And Receivers, Electrocardiograph, Telephone devices
- MAC 5 A4Ge Medical Systems Information Technologies, Inc. · TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE1 recall0 reports
- AfibAlert / hom ecg+ V2.0Lohman Technologies, LLC · Transmitters And Receivers, Electrocardiograph, Telephone18 reports
- LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-Universal Gateway-VerizonLifewatch · Transmitters And Receivers, Electrocardiograph, Telephone3 reports
- LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-InternationalLifewatch · Transmitters And Receivers, Electrocardiograph, Telephone3 reports
- Rhythm Express RX-1 miniVivaquant, Inc. · Transmitters And Receivers, Electrocardiograph, Telephone2 reports
- Kardia Mobile AC-009Alivecor, Inc. · Transmitters And Receivers, Electrocardiograph, Telephone2 reports
- LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-Brigadier-VerizonLifewatch · Transmitters And Receivers, Electrocardiograph, Telephone1 report
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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