Radius-PPG 4585Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10843997014684), received between Nov 7, 2021 and Sep 9, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Overheating of Device; Overheating of Device

  PER MEDWATCH RECEIVED: "PATIENT AWOKE TO WARMTH FROM MASIMO WRIST DEVICE (RECENT HISTORY WITHIN FACILITY OF FORCEFUL SEPARATION OF DEVICES)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396710 ↗
• MalfunctionAug 31, 2022Material Separation; Material Separation

  PER MEDWATCH RECEIVED: "BATTERY COMPARTMENT ON WRIST DEVICE FORCEFULLY SEPARATED WHILE IN USE ON PATIENT." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332428 ↗
• MalfunctionJul 29, 2022Material Separation; Material Separation

  PER MEDWATCH RECEIVED: "BATTERY COMPARTMENT OF WRISTBAND FORCEFULLY SEPARATED/EXPLODED WHILE IN USE ON PATIENT." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136097 ↗
• MalfunctionJul 28, 2022Material Separation; Material Separation

  PER MEDWATCH RECEIVED: BATTERY COMPONENT OF WRIST BAND FORCEFULLY SEPARATED OR EXPLODED WHILE IN USE ON PATIENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126855 ↗
• MalfunctionJan 28, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR SUDDENLY STOPS WORKING AFTER 10-30 MINUTES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389543 ↗
• MalfunctionNov 24, 2021Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE SENSOR "WAS LOSING CONNECTIVITY." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872404 ↗
• MalfunctionNov 11, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THE SENSOR WAS CONSISTENTLY READING OXYGEN 3%-5% LOWER THAN THE SITE'S OXIMETER. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801100 ↗
• MalfunctionNov 7, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR MALFUNCTIONED AND STOPPED WORKING IN THE MIDDLE OF THE STUDY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763520 ↗