MasimoSET® LNCS® Inf Infant Pulse Oximeter Adhesive Sensor 2328Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10843997000915), received between Dec 10, 2024 and Apr 7, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Low Readings

  THE CUSTOMER REPORTED A SEVERE DESATURATION OCCURRED, DROPPING TO 70%, WITH A GOOD PLETHYSMOGRAPHY WAVEFORM AND NO IMPROVEMENT DESPITE INCREASING THE FIO2.NO RECURRENCE WAS OBSERVED, AND THE PATIENT'S POSTOPERATIVE RECOVERY WAS UNEVENTFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811957 ↗
• MalfunctionMar 30, 2026Peeled/Delaminated

  THE CUSTOMER REPORTED THAT "WITHIN THE PAST TWO MONTHS, I HAVE NOTICED THAT THE WIRES BECOME EXPOSED ON OUR PULSE OX CORDS WHEN ATTEMPTING TO CHANGE OUT THE BROWN STICKER. THE STICKER REMAINS ADHERED TO THE WHITE PLASTIC PIECE THAT TYPICALLY COVERS THE WIRES, REQUIRING THE ENTIRE CORD TO BE REPLACED. I DISCUSSED THIS WITH MANY NURSES ON MY UNIT, WHO ALL AGREED THAT THIS IS NOT AN ISOLATED INCIDENT. I BELIEVE THAT THIS HAS AFFECTED BOTH THE NEONATAL AND INFANT CORDS". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734702 ↗
• MalfunctionDec 10, 2024Unable to Obtain Readings; Unable to Obtain Readings

  PER MEDWATCH MW5161123, THE CUSTOMER REPORTED THAT THE "PULSE OX KEPT FLASHING BUT WOULD NOT GIVE A READING". THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893771 ↗
• MalfunctionDec 10, 2024Unable to Obtain Readings; Unable to Obtain Readings

  PER MEDWATCH MW5161122, THE CUSTOMER REPORTED THAT "THEY COULDN'T GET A GOOD PULSE OX READING ON A PEDIATRIC PATIENT WITH THE INFANT PULSE OXIMETER ADHESIVE SENSOR... THE PULSE OX KEPT FLASHING BUT WOULD NOT GIVE A READING." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893481 ↗