MasimoSET® M-LNCS™ YI SpO2 Multisite Adult Reusable Sensor 2505Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843997003254), received between Oct 2, 2017 and Jan 24, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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.

• MalfunctionJan 24, 2020Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "INTERMITTENT MONITORING." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9630165 ↗
• MalfunctionJan 24, 2020Sensing Intermittently; Sensing Intermittently

  THE CUSTOMER REPORTED: "INTERMITTENT MONITORING." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9630161 ↗
• MalfunctionJun 29, 2018Sensing Intermittently; Sensing Intermittently

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651205 ↗
• MalfunctionOct 2, 2017Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  THE CUSTOMER REPORTED FIFTEEN M-LNCS Y-I SENSORS, SOME OCCUR SENSOR OFF, SOME OCCUR REPLACE SENSOR, SOME SPO2 AND BPM ARE VERY LOW, ALL THE ISSUES ARE INTERMITTENT, THE CUSTOMER COULDN'T MATCH THE ISSUE WITH THE CORRESPONDING SENSOR. NO PATIENT INCIDENT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908238 ↗
• MalfunctionOct 2, 2017Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  THE CUSTOMER REPORTED FIFTEEN M-LNCS Y-I SENSORS, SOME OCCUR SENSOR OFF, SOME OCCUR REPLACE SENSOR, SOME SPO2 AND BPM ARE VERY LOW, ALL THE ISSUES ARE INTERMITTENT, THE CUSTOMER COULDN'T MATCH THE ISSUE WITH THE CORRESPONDING SENSOR. NO PATIENT INCIDENT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907170 ↗
• MalfunctionOct 2, 2017Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  THE CUSTOMER REPORTED FIFTEEN M-LNCS Y-I SENSORS, SOME OCCUR SENSOR OFF SOME OCCUR REPLACE SENSOR, SOME SPO2 AND BPM ARE VERY LOW, ALL THE ISSUES ARE INTERMITTENT, THE CUSTOMER COULDN'T MATCH THE ISSUE WITH THE CORRESPONDING SENSOR. NO PATIENT INCIDENT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907150 ↗