LifeWatch Mobile Cardiac Telemetry 3-Lead MCT 3L-Universal Gateway-VerizonRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850725007033), received between Aug 29, 2019 and Mar 11, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 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: Hypersensitivity/Allergic reaction; Patient Problem/Medical Problem

  MAUDE report 9820058 ↗
• InjuryOct 3, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  ON (B)(6) 2019, PATIENT REPORTED THAT SHE PLACED THE MCT-3L SENSOR BATTERY PROVIDED IN THE KIT IN A BATTERY RECHARGING SYSTEM (NOT PROVIDED BY THE COMPANY) AND THE BATTERY EXPLODED CAUSING FIRE AND HARM TO HER MOTHER. THE PATIENT REPORTED IT BURNED HER BLANKET AND COUCH. SHE ALSO REPORTED THE BATTERY FLEW AND HIT HER MOTHER IN THE CHEST WHO HAS A PACEMAKER. IT ALSO CAUSED HER MOTHER'S DRESS TO GET ON FIRE AND CAUSED BURNS. THE PATIENT REPORTED THAT HER MOTHER WAS HOSPITALIZED AND STAYED FOR 5 DAYS. NOTE: BECOME AWARE DATE IS (B)(6) 2019, WHICH IS THE DATE THAT THE PATIENT CONTACTED LIFEWATCH SERVICES, INC. TO REPORT THE EVENT ((B)(4)).

  Patient problems: Burn(s); Caustic/Chemical Burns

  MAUDE report 9151144 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, PATIENT NOTIFIED (B)(4), INC. OF SKIN IRRITATION/REACTION. THE SYMPTOMS WERE DESCRIBED BY THE PATIENT AS "ITCHING, SWOLLEN, REDNESS RASH AND THROAT FELT LIKE IT WAS CLOSING." NOTE: BECOME AWARE DATE IS (B)(6) 2019, PER COMPLAINT CASE GENERATED ((B)(4)).

  Patient problems: Irritability; Skin Irritation

  MAUDE report 8945876 ↗