Nellcor MAXNIRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 20884522040379), received between Nov 6, 2017 and Sep 29, 2026 — classified as 1 death, 12 injuries, 84 malfunctions.

The most frequently reported specific device problem is “High Readings” (27 reports).

1 other recall cover devices cleared under the same FDA submission (K012891); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Analyze Signal; Delayed Program or Algorithm Execution

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940430 ↗
• MalfunctionJun 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER USING THE SENSOR, SKIN REDNESS (ERYTHEMA) WAS OBSERVED ON THE SOLE OF THE PATIENT'S FOOT.

  Patient problems: Erythema

  MAUDE report 25569062 ↗
• MalfunctionJun 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING APPLICATION, SKIN LESION OCCURRED. THE SEAMS OF THE SENSOR FELT A LITTLE HARDER THAN OTHER SENSORS.

  Patient problems: Localized Skin Lesion

  MAUDE report 25451471 ↗
• MalfunctionMay 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING APPLICATION, SKIN REDNESS ON THE SOLES OF THE FEET CONSISTENT WITH A SKIN LESION, WAS OBSERVED. IT WAS ALSO NOTED THAT THE SEAMS OF THE SENSOR FELT HARD DURING USE.

  Patient problems: Localized Skin Lesion

  MAUDE report 25330481 ↗
• MalfunctionMay 29, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING APPLICATION, SKIN REDNESS OCCURS ON THE SOLES OF THE FEET, CONSISTENT WITH A SKIN LESION. IT WAS ALSO NOTED THAT THE SEAMS OF THE SENSOR FELT A LIITLE HARDER.

  Patient problems: Localized Skin Lesion

  MAUDE report 25330418 ↗
• MalfunctionMay 4, 2026Incorrect Measurement

  IT WAS REPORTED THAT, DURING USE, THERE WAS A DEFECT IN DISPLAYING THE HEART RATE AND OXYGEN SATURATION READINGS. THE ISSUE OCCURRED TWICE WITH TWO SENSORS. AN URGENT SENSOR CHANGE AND URGENT SCOPE CHANGE WERE PERFORMED, AND A SENSOR OF THE SAME REFERENCE WAS THEN USED TO COMPLETE THE ACT. THERE WAS A DELAY IN PATIENT CARE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25069063 ↗
• MalfunctionMay 4, 2026Incorrect Measurement

  IT WAS REPORTED THAT, DURING USE, THERE WAS A DEFECT IN DISPLAYING THE HEART RATE AND OXYGEN SATURATION READINGS. THE ISSUE OCCURRED TWICE WITH TWO SENSORS. AN URGENT SENSOR CHANGE AND URGENT SCOPE CHANGE WERE PERFORMED, AND A SENSOR OF THE SAME REFERENCE WAS THEN USED TO COMPLETE THE ACT. THERE WAS A DELAY IN PATIENT CARE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25069042 ↗
• MalfunctionMar 20, 2026Insufficient Heating; Temperature Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING USE, THE SENSOR OF THE DEVICE BECAME WARM OR HOT, AND THE CHILD CRIED. A SMALL AMOUNT OF REDNESS WAS BRIEFLY VISIBLE WHEN THE SENSOR WAS REMOVED AND DISAPPEARED IMMEDIATELY AFTER ACCEPTANCE. NO PERMANENT REDNESS AND NO BURN BLISTER.

  Patient problems: Burning Sensation

  MAUDE report 24656469 ↗
• MalfunctionJul 24, 2025Low Readings; Low Readings

  IT WAS REPORTED THAT THE DEVICE SENSOR WAS TESTED BEFOREHAND AND DISPLAYED A NORMAL READING. HOWEVER, DURING USE IN A HOSPITAL SETTING, THE DEVICE DISPLAYED A LOW SPO2 READING OF 76%, COMPARED TO 98% ON THE REUSABLE SENSOR, WHILE THE SENSOR WAS APPLIED TO THE INFANT'S FINGER. THE SENSOR USED WAS AN INFANT/ADULT SENSOR, INTENDED FOR PATIENTS WEIGHING LESS THAN 3 KG OR MORE THAN 40 KG. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592862 ↗
• MalfunctionMay 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE, THE SENSOR SHOCKED THE PATIENT AND THE PARENT WHO TRIED TO ASSIST.

  Patient problems: Electric Shock

  MAUDE report 21960692 ↗
• MalfunctionMay 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE, THE SENSOR ELECTRICALLY SHOCKED BOTH THE PATIENT AND THE PARENT WHO TRIED TO ASSIST. THE SENSOR WAS PLACED ON THE PATIENT'S FOOT. PRIOR TO THE EVENT, THE SENSOR HAD BEEN IN USE FOR TWO DAYS.

  Patient problems: Electric Shock

  MAUDE report 21957595 ↗
• MalfunctionApr 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A SENSOR WAS PLACED ON THE BABY'S FOOT FOR FIVE HOURS. IT WAS MENTIONED THAT THE PATIENT SUFFERED A FIRST DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 21773907 ↗
• MalfunctionFeb 6, 2025Failure to Analyze Signal; Failure to Analyze Signal

  IT WAS REPORTED THAT THERE WAS A DELAY IN CARE FOR NEONATAL PATIENT DUE TO A READING ISSUE WITH THE SENSOR, WHICH RESULTED IN NO SPO2 READING. THE SENSOR LIGHT APPEARED TO BE LESS BRIGHT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21321415 ↗
• MalfunctionJan 22, 2025Failure to Analyze Signal; Failure to Analyze Signal

  IT WAS REPORTED THAT THERE WAS A READING ISSUE WITH THE SENSOR, SPECIFICALLY NO SPO2 READING WHICH RESULTED TO A DELAY IN CARE FOR N EONATAL PATIENT. THE SENSOR LIGHT APPEARED TO BE LESS BRIGHT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21211648 ↗
• MalfunctionNov 11, 2024Failure to Analyze Signal; Low Readings; Failure to Analyze Signal; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT DISPLAYED ABNORMALLY WHEN TURNED ON. THE PATIENT WAS NOT CONNECTED BUT THE BLOOD OXYGEN DISPLAY WAS 100%, AND THE PULSE RATE VARIED BETWEEN 26-65. THE SENSOR WAS DISCONNECTED FROM THE SENSOR SEGMENT OF THE MONITOR AND THERE WAS NO DATA DISPLAY THEN THE MONITORING WAS NORMAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652484 ↗
• MalfunctionOct 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE RED LIGHT ON THE SENSORS CAUSED BURNS ON PATIENT'S SKIN. SENSOR PLACED ON LEFT HAND ON THE WRIST AND BELOW THE RIGHT FOOT, STARTED TO USE THE PROBE FROM (B)(6), PATIENT WAS A 6 DAY OLD PREMATURE, DELIVERED AT 31/40. PATIENT HAD SMALL BLISTERS. AFFECTED THE TOP LAYER OF THE SKIN.

  Patient problems: Burn(s)

  MAUDE report 20350401 ↗
• MalfunctionSep 30, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE RED LIGHT ON THE SENSORS CAUSED BURNS ON PATIENT'S SKIN. SENSOR PLACED ON LEFT HAND ON THE WRIST AND BELOW THE RIGHT FOOT, STARTED TO USE THE PROBE FROM THE 10TH SEPTEMBER, PATIENT WAS A 6 DAY OLD PREMATURE, DELIVERED AT 31/40. PATIENT HAD SMALL BLISTERS. AFFECTED THE TOP LAYER OF THE SKIN.

  Patient problems: Burn(s)

  MAUDE report 20339700 ↗
• MalfunctionJun 27, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD HIGH SPO2 READING. THE SENSOR WAS APPLIED ON THE FINGER WITH A SUPPLEMENTAL TAPE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624887 ↗
• MalfunctionMay 21, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD HIGH SPO2 READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359227 ↗
• MalfunctionMay 21, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD HIGH SPO2 READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359170 ↗
• MalfunctionMay 20, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A HIGH SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354302 ↗
• MalfunctionMay 20, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD HIGH SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354017 ↗
• MalfunctionMay 20, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A HIGH SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354009 ↗
• MalfunctionMay 20, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD HIGH SPO2 READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353968 ↗
• MalfunctionMay 17, 2024High Readings; High Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD HIGH SPO2 READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

• Z-0664-05 · Oct 18, 2004 · Terminated
  Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.