MasimoSET LNCS® YI SpO2 Multisite Reusable Sensor 2258Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843997000062), received between Jun 11, 2017 and Jan 21, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2021Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT THE DEVICE PROVIDED LOW MEASUREMENTS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11210535 ↗
• MalfunctionMay 31, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THE SENSOR SOMETIMES GIVES NORMAL READINGS BUT MOSTLY GIVES LOW READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660344 ↗
• MalfunctionMar 29, 2018Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED WHEN COMPARING THE LNCS YI SENSOR TO THE RELION PULSE OXIMETER THE SPO2 IS INACCURATE. THE SENSOR IS YIELDING 40% SPO2. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384390 ↗
• MalfunctionJun 25, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THAT THE SENSORS HAVE INTERMITTENT SIGNAL. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666025 ↗
• MalfunctionJun 11, 2017Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE DEVICE WILL ONLY GIVE READINGS IN THE 80'S, COMPARED TO OTHER SENSORS THAT ARE READING "MORE NORMAL" (IN THE 90'S). NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6632867 ↗

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-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
• 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-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