MasimoSET® LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor 1859Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10843997000298), received between Mar 23, 2018 and Jun 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Unraveled Material; Structural Problem; Unintended Electrical Shock

  PER MEDWATCH REPORT MW5187461, "WHILE PATIENT USING ADULT PULSE OXIMETER ADHESIVE SENSOR ON FINGER AND URINAL - WIRES EXPOSED STILL PROTECTED WITH COVERING BUT PATIENT BELIEVES HE URINATED ON WIRES AND RECEIVED A LIGHTENING BOLT SENSATION UP HIS ARM."

  Patient problems: Electric Shock

  MAUDE report 25345696 ↗
• MalfunctionOct 11, 2024Unable to Obtain Readings; Unable to Obtain Readings

  PER MEDWATCH (B)(4), THE CUSTOMER REPORTED THAT THE SENSOR SPO2 [IS] NOT READING, AND THE GE BESIDE MONITOR DISPLAYS ¿FAULTY PROBE'. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428841 ↗
• MalfunctionSep 16, 2024

  MASIMO LNCS ADTX SPO2: ADULT PULSE OXIMETER ADHESIVE SENSOR. LOT # 24AM1. UPON CHANGING O2 PROBE FOR PATIENT, APPLIED NEW PROBE TO PATIENT'S FINGER, ATTACHED CORRECTLY TO BEDSIDE MONITOR CABLE, SPO2 NOT READING, AND NOTICE ON GE BEDSIDE MONITOR "FAULTY PROBE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223753 ↗
• MalfunctionAug 5, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SPO2 CUT OUT WITH NO POSITION CHANGE OR PATIENT MOVEMENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285270 ↗
• MalfunctionJun 30, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED READINGS DROPPED OUT SEVERAL TIMES DURING A CASE ON THE OPERATING ROOM. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12096374 ↗
• MalfunctionMar 23, 2018Incorrect Measurement; Sensing Intermittently; Incorrect Measurement; Sensing Intermittently

  THE CUSTOMER REPORTED THE PULSE OX HAD VARIATIONS WITH RANDOM DIPS NOT TRUSTED BY NURSING. SATS WOULD GO BACK UP AS WELL AS DROP OUT DURING USE. THEY CHECKED THE PATIENTS SAT WITH A GE DINAMAP WITH A REUSABLE SENSOR TO MAKE SURE THE PATIENT WAS OKAY AND IT GAVE THEM A SAT OF 95%. THEY DO NOT TRUST THE TELEBOX SAT WITH THE DISPOSABLE SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7368342 ↗