MasimoSET LNCS® DCI® SpO2 Adult Reusable Finger Clip Sensor 1863Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00843997000406), received between Feb 25, 2018 and Nov 11, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Sensing Intermittently” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K051212); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025High Readings; High Readings

  THE CUSTOMER REPORTED THAT A "PATIENT'S SPO2 WAS READING 100% WITH A GOOD PLETH HOWEVER OBSERVED THAT THE PATIENT DIDN'T LOOK GOOD. THEY DREW AN ARTERIAL BLOOD GAS. THE ARTERIAL BLOOD GAS REPORTED SPO2 83 WITH A PAO2 OF 48". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528720 ↗
• MalfunctionJul 16, 2025Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR "SEEMS TO BE MALFUNCTIONING NOW AS THE LIGHT IS INTERMITTENT AND WE KEEP LOSING TRACE OF PATIENTS' OXYGEN LEVELS DURING SURGERY." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527558 ↗
• MalfunctionMay 5, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780428 ↗
• MalfunctionJun 26, 2020Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED INACCURATE MEASUREMENT WHEN COMPARED TO BLOOD GAS RESULTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203571 ↗
• MalfunctionMay 1, 2020Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE MEASUREMENT IS SPORADICALLY INTERRUPTED AND THE CABLE IS BROKEN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10017928 ↗
• MalfunctionDec 10, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE SENSOR IS TOO LOOSE AND THE OXYGEN STATUS IS NOT CORRECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8147659 ↗
• MalfunctionAug 7, 2018Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED AN INACCURATE READING; SPO2 VALUE TOO LOW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7760299 ↗
• MalfunctionMay 7, 2018Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE SENSOR WORKED INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493292 ↗
• MalfunctionFeb 25, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED A FAULTY SENSOR ALWAYS READS 80 EVEN WHEN NOT CONNECTED TO A PATIENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295223 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051212. One submission often covers many models, so check the product and lot details in each record.

• Z-1986-2023 · Apr 21, 2023 · Open, Classified
  Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
• Z-1985-2023 · Apr 21, 2023 · Open, Classified
  Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
• Z-2641-2017 · Apr 4, 2016 · Terminated
  Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient und
• Z-2642-2017 · Apr 4, 2016 · Terminated
  MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures,
• Z-2640-2017 · Apr 4, 2016 · Terminated
  SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human pa