MasimoSET® LNCS® Neo Neonatal/Adult Pulse Oximeter Adhesive Sensor 2320Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10843997000892), received between Apr 18, 2017 and May 1, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Stops Intermittently” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED "BEDSIDE REGISTERED NURSE (RN) DISCOVERED OXYGEN SATURATION PROBE WAS FRAYED WITH EXPOSED WIRES ON INFANT'S SKIN. NO HARM TO PATIENT." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226454 ↗
• MalfunctionMay 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED VIA THE MEDWATCH REPORT "PULSE OXIMETER LOW NOISE CABLED SENSOR (LNCS) FOUND TO HAVE EXPOSED WIRES". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226446 ↗
• MalfunctionSep 23, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE PULSE OXIMETER CAN SUDDENLY NOT RECOGNIZE THE DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523549 ↗
• MalfunctionSep 23, 2021Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED THE PULSE OXIMETER CAN SUDDENLY NOT RECOGNIZE THE DEVICE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523451 ↗
• MalfunctionFeb 19, 2021High Readings; High Readings

  THE CUSTOMER REPORTED THE DEVICE IS READING HIGHER THAN THE RESULT OF ABG. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11351052 ↗
• MalfunctionJul 3, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE PATIENT WAS READING LOW SAO2, PATIENT DID NOT APPEAR IN DISTRESS BUT WAS JUST TRACHED AND ON SEDATION. OXYGEN SATURATION READING 84% WITH PERFUSION OF 0.35-.065. A FOREHEAD PROBE WAS TRIED WITH CHANGE IN READING TO 90%, BUT NO SIGNIFICANT CHANGE IN PERFUSION THE FINGER PROBE CHANGED TO ALTERNATE LOCATION, AGAIN WITH NO SIGNIFICANT CHANGE IN PERFUSION OR READING. THE PATIENT WAS GIVEN 100% FIO2 TO SEE IF SATURATION WOULD INCREASE, IT DID NOT. NON-DISPOSABLE FINGER PROBE TRIED, PERFUSION ONLY INCREASED TO 0.7 BUT NOW WITH SAT OF 95% THE EAR CLIP DID NOT READ AT ALL, THE RANGE OF SATS OBTAINED FROM THE PT WERE 84-95%, ALL WITH A PERFECT PLETH AND ALL WITH A PERF IN THE 0.5-0.65 RANGE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657491 ↗
• MalfunctionMay 7, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE SATURATION ONLY REACHES 90-95%. THE INACCURACY WAS DETECTED BY THE HOME USER FIRST WHEN MONITORING THEIR OWN CHILD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493291 ↗
• MalfunctionNov 17, 2017Material Separation; Material Separation

  THE CUSTOMER REPORTED A MASIMO LNCS NEO-3 SPO2 PULSE OXIMETER ADHESIVE SENSOR FROM THE NICU AT IU NORTH THAT WAS ON A PATIENT, THE STAFF REMOVED IT FROM THE PATIENT WHEN THEY NOTED MINOR HARM DUE TO THE SENSOR HAVING EXPOSED WIRES.

  Patient problems: Skin Tears

  MAUDE report 7043521 ↗
• MalfunctionAug 11, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE PROBE STOPPED WORKING INT THE MIDDLE OF AN OR CASE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790506 ↗
• MalfunctionAug 11, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THE PROBE STOPPED WORKING INT THE MIDDLE OF AN OR CASE. NO PATIENT IMPACT OR CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6790502 ↗
• MalfunctionAug 9, 2017Device Alarm System; Device Operates Differently Than Expected; Device Alarm System; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "IF THE PROBE GOES BAD (WE HAVE HAD A FEW), THERE IS NO ALARM, THE PATIENT IS THEN HOOKED UP WITH NO SATS ON THE MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778954 ↗
• MalfunctionAug 9, 2017Device Alarm System; Device Operates Differently Than Expected; Device Alarm System; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "IF THE PROBE GOES BAD (WE HAVE HAD A FEW), THERE IS NO ALARM, THE PATIENT IS THEN HOOKED UP WITH NO SATS ON THE MONITOR." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778934 ↗
• MalfunctionApr 28, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED, ¿I HAD ANOTHER SENSOR THAT WAS PROVIDED TO ME THAT WAS WORKING ON AN ICU PATIENT, THEN ALL OF A SUDDEN STOPPED WORKING, AND DID NOT ALARM ON THE GE MONITOR ON WEST 4. THIS HAS BEEN CONSISTENT WITH FEEDBACK FROM WEST 3 AND WEST 4. THIS IS OUR 5TH SENSOR THAT THIS HAS OCCURRED WITH." THE ACCOUNT STATES THAT THE NURSE SAW THE SENSOR FLAT-LINE WITH NO ALARM SOUNDING BY THE GE MONITOR. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529704 ↗
• MalfunctionApr 18, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THEY HAVE A CHILD, (B)(6), MALE, (B)(6), WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN IN THE NICU. SHE REPORTS THAT A NURSE HAS BEEN STRUGGLING SINCE SUNDAY, (B)(6), TO GET A PULSE OXIMETRY READING. THE NURSE REPORTS THAT IT COMES AND GOES, WITH THE STARS GOING UP AND DOWN ON THE GE MONITOR. THEY HAVE TRIED MOVING THE SENSOR, DISCONNECTING AND RECONNECTING; MAKING SURE SENSOR IS LINED UP CORRECTLY. THEY HAVE ALSO TRIED MULTIPLE SENSORS WHICH SEEM TO WORK FOR A WHILE THEN STOP WORKING. MONITORING WAS DONE SIMULTANEOUSLY ON BOTH THE GE B850 MONITOR AND GE TRAM DUE TO THE PATIENT¿S CLINICAL CONDITION. THE NURSE REPOSITIONED THE PRE- AND POST- DUCTAL LNCS SENSORS MULTIPLE TIMES AFTER INITIALLY WORKING FOR A BRIEF TIME. FOR THE PRE-DUCTAL SITE WITH THE LNCS NEO SENSOR, THEY FIRST STARTED WITH THE (R) HAND, THEN (R) WRIST, THEN (R) FINGERS [EMITTER/DETECTOR OVER ONE FINGER WITH SENSOR TAPE WRAPPED AROUND BOTH]. FOR THE POST-DUCTAL SITE, THEY HAD THE LNCS NEO SENSOR ON THE (L) HAND, THEN (L) FOOT, THEN (L) TOES [AGAIN WITH THE EMITTER/DETECTOR LINED UP OVER ONE TOE, BUT WRAPPED AROUND TWO]. EACH TIME THE SENSOR WAS APPLIED, A POSEY WAS OVER THE SENSOR SITE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499852 ↗