Rhythm Express RX-1 miniRecalls & reported problems
Vivaquant, Inc. · The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network. The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860000272407), received between Oct 25, 2025 and Aug 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem2
Patient problems
- Blister2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2026Electrical /Electronic Property Problem
Patient problems: Blister
MAUDE report 50166350 ↗MalfunctionOct 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IBC FROM PATIENT DUE TO DEVICE NOT LIGHTING UP INDICATING A CHARGE, TRIED SOFT RESET AND DEVICE ISN'T VIBRATING OR LIGHTING UP. DEVICE IS UNRESPONSIVE AND PATIENT STATED THAT EARLY THIS MORNING THE HOUSING OF THE DEVICE STARTED TO GET VERY HOT AND NOW HE HAS A BLISTER UNDER WHERE THE HOUSING WAS SITTING ON HIS CHEST.
Patient problems: Blister
MAUDE report 23386929 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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