MasimoSET® LNCS® Neo Neonatal/Adult Pulse Oximeter Adhesive Sensor 2329Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10843997000922), received between Mar 1, 2017 and Jun 28, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2026Material Perforation

  PER MEDWATCH (B)(4): "EXPOSED WIRE WAS NOTED ON THE NEW, FRESH OUT OF PACKAGE PULSE OXIMETER. REPLACED WITH ANOTHER NEW PULSE OX. MASSIMO REFERENCE NUMBER (B)(4) FROM PACKAGING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25647475 ↗
• MalfunctionMay 10, 2026Incorrect Measurement; Low Readings

  THE CUSTOMER REPORTED "IN ED TRIAGE 2 SMALL BABY SENSOR FIRST CONNECTED TO CABLE THEN APPLIED TO RT FOOT ON OUTSIDE AND PLACEMENT WAS GOOD. THE PLETH WAS BAD GOT VALUES PLS 74 SPO2 75 PI 6.6. DISCONNECTED RECONNECTED NO CHANGE CHANGED TO MAX SENS. NO CHANGE. DISCONNECTED CHANGED TO RT OUTSIDE HAND IDENTICAL RESULT. GOT A NEW NEO SENSOR PLACED ON SAME FOOT BY CS NOT RN SAME START PLETH CORRUPT SUDDENLY GOT SIMILAR MEASUREMENT DISCONNECTED AND DISCONNECTED X 2 THEN GOT PR 133 SPO2 95 CORRELATING WITH THE CLINICAL PICTURE OF THE PATIENT". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133279 ↗
• MalfunctionMay 10, 2026Incorrect Measurement; Low Readings

  THE CUSTOMER REPORTED "IN ED TRIAGE 2 SMALL BABY SENSOR FIRST CONNECTED TO CABLE THEN APPLIED TO RT FOOT ON OUTSIDE AND PLACEMENT WAS GOOD. THE PLETH WAS BAD GOT VALUES PLS 74 SPO2 75 PI 6.6. DISCONNECTED RECONNECTED NO CHANGE CHANGED TO MAX SENS. NO CHANGE. DISCONNECTED CHANGED TO RT OUTSIDE HAND IDENTICAL RESULT. GOT A NEW NEO SENSOR PLACED ON SAME FOOT BY CS NOT RN SAME START PLETH CORRUPT SUDDENLY GOT SIMILAR MEASUREMENT DISCONNECTED AND DISCONNECTED X 2 THEN GOT PR 133 SPO2 95 CORRELATING WITH THE CLINICAL PICTURE OF THE PATIENT". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133278 ↗
• MalfunctionMar 30, 2026Peeled/Delaminated

  THE CUSTOMER REPORTED THAT "WIRES IN OUR PULSE OX SENSOR HAVE BECOME EXPOSED WHEN ATTEMPTING TO CHANGE OUT THE BROWN FABRIC STICKER (REPLACEMENT TAPE)... NEW PULSE OX SENSOR NOTED TO HAVE EXPOSED WIRES WHEN REMOVING FROM PACKAGE". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24736659 ↗
• MalfunctionJan 21, 2025Unable to Obtain Readings; Unable to Obtain Readings

  PER MEDWATCH #: (B)(4), THE CUSTOMER REPORTED THAT THE SENSOR WAS "CONNECTED TO THE MONITOR AND WOULD NOT READ." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199539 ↗
• MalfunctionDec 27, 2024

  CONNECTED TO THE MONITOR AND WOULD NOT READ. BIOMED HAD CHECKED MONITOR AND WAS FUNCTIONING AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025839 ↗
• MalfunctionJul 22, 2024Unable to Obtain Readings; Unable to Obtain Readings

  PER MEDWATCH REPORT: "PULSE OX NOT WORKING. CABLE SWITCHED OUT TO ISOLATE WHAT WAS CAUSING THE ISSUE AND THE PULSE OX STILL WOULD NOT FUNCTION. TRIED SEVERAL PROBES FROM THE SAME LOT NUMBER AND THEY WOULD NOT WORK. FOUND A DIFFERENT LOT NUMBER AND THEY WORKED. ALSO FOUND ANOTHER BOX WITH THE SAME LOT NUMBER AS THE ONES THAT WOULD NOT WORK AND THEY WORKED". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19802214 ↗
• MalfunctionJul 21, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE PROVIDED HIGH SPO2 READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080270 ↗
• MalfunctionMar 18, 2022Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE DEVICE STOPPED READING SPO2 FOR NEARLY 2 MINUTES. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810420 ↗
• MalfunctionMay 7, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE PULSE OXIMETER SHOWED SATURATION AT 99% COMPARED TO ARTERIAL BLOOD GASES SHOWING SATURATION AT 85%. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790846 ↗
• MalfunctionFeb 26, 2021Loss of or Failure to Bond; Sensing Intermittently; Material Split, Cut or Torn; Loss of or Failure to Bond; Sensing Intermittently; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THE SENSOR GLUE WAS EASILY DISSOLVED AFTER ONLY A FEW HOURS OF USE, ALSO THE CABLE PROTECTION WAS FALLING OFF QUICKLY SO THAT THE WIRES WERE EXPOSED AND THE MEASURING WAS PARTLY INTERRUPTED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11387106 ↗
• MalfunctionMar 1, 2019High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE WAS PROVIDING HIGH SPO2 READINGS WHEN COMPARED TO THE VALUES RECEIVED FROM BLOOD GAS TESTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383727 ↗
• MalfunctionFeb 14, 2019Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE OXIMETRY SENSOR PRESENTED INTERMITTENT READING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341950 ↗
• MalfunctionDec 14, 2018Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  THE CUSTOMER REPORTED SENSORS WERE FOUND TO BE FAULTY ON FIVE OCCASIONS WITHIN THE SAME DEPARTMENT AND TIME FRAME. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED. THE MAUDE DATABASE DESCRIPTION OF THE ISSUE (MW5081615) READS: "FIVE DIFFERENT PTS THAT HAD EITHER NO SAO2 READING OR WRONG SAO2 READINGS WITH THE PULSE OXIMETER PROBES BY MASIMO, PART #2329."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8166562 ↗
• MalfunctionJul 29, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED INACCURATE SPO2 READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7729914 ↗
• MalfunctionJul 13, 2018High Readings; High Readings

  THE CUSTOMER REPORTED INACCURATELY HIGH SPO2 READINGS ON A HYPOXIC PATIENT IN THE ICU. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7684508 ↗
• MalfunctionFeb 5, 2018Defective Alarm; Defective Alarm

  THE CUSTOMER REPORTED THE RAD-97 WAS TAKING UP TO 30 SECONDS TO GIVE A SENSOR OFF MESSAGE WHEN THE SENSOR WAS REMOVED. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7243128 ↗
• MalfunctionOct 9, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED: "IN THE NICU THERE WAS AN INFANT WHO WAS PINK BUT THE REPROCESSED SENSOR PULSE OXIMETER NEONATAL ADHESIVE KEPT FLUCTUATING BETWEEN A HIGH OXYGEN SATURATION AND A LOW OXYGEN SATURATION NUMBER. THIS CERTAIN SCENARIO HAS HAPPENED SEVERAL TIMES PER A NICU RN ON AN INFANT SHE WAS CARING FOR." NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6933535 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED: "THERE WAS AN INFANT IN THE NICU AND BY THE TIME THE REPROCESSED SENSOR PULSE OXIMETER NEONATAL ADHESIVE PICKED UP THAT THE INFANT'S SATURATION LEVEL WAS LOW AND NOTIFIED THE RN, THE INFANT WAS BLUE."

  Patient problems: Cyanosis; Low Oxygen Saturation

  MAUDE report 6933529 ↗
• MalfunctionJun 25, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THESE SENSORS WERE PLACED ON A NEWBORN BABY, AND WERE NOT ABLE TO ACCURATELY READ THE PULSE EVEN AFTER SEVERAL MINUTES, WHILE ANOTHER TECHNOLOGY DID. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666021 ↗
• MalfunctionMar 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SENSORS HAD NOT WORKING CORRECTLY IN OR & PACU OVER THE LAST 30 DAYS. THE SENSOR WOULD COME WITH THE PATIENT FROM THE OR. IT WOULD WORK FOR A FEW SECONDS TO TWO MINUTES AND ¿FLASH OUT". PROBLEM OCCURRED WITH SENSORS FROM CARDINAL HEALTH PRE-OP PACKS AS WELL AS LOOSE MASIMO SENSOR STOCK. NO ERROR MESSAGE OR AUDIBLE ALARM WAS MENTION. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6370815 ↗