Nellcor MAXARecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20884522040089), received between May 24, 2018 and Apr 17, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A SENSOR WAS ATTACHED TO A PATIENT¿S FINGER FOR OVER 8 HOURS AND REMAINED IN PLACE FOR A FEW DAYS. DURING USE, THE PATIENT¿S FINGER WAS REPORTED TO HAVE A MOISTURE-RELATED SKIN INJURY, INCLUDING A BURN, BLISTERING, AND THE TOP LAYER OF THE SKIN WAS PEELING OFF. THE INSTRUCTIONS FOR USE, INCLUDING WARNINGS/PRECAUTIONS AND THE RECOMMENDATION TO CHECK THE SENSOR AFTER SO MANY HOURS TO ASSESS SKIN INTEGRITY, WERE REVIEWED AND COMMUNICATED. THE PATIENT WAS DISCHARGE SO THE STATUS OF HEALING PROCESS WAS UNKNOWN.

  Patient problems: Skin Maceration

  MAUDE report 24916796 ↗
• MalfunctionAug 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT IN THE INTENSIVE CARE UNIT HAD A SENSOR PLACED ON THE LEFT INDEX FINGER FOR APPROXIMATELY 10 HOURS DURING TREATMENT. ABOUT 30 MINUTES AFTER SENSOR PLACEMENT, SWELLING OF THE FINGER WAS OBSERVED, FOLLOWED BY INFLAMMATION AND THE DEVELOPMENT OF ITCHY, BLISTER-LIKE BUBBLES AT THE FINGERTIP, SPECIFICALLY IN THE AREA ASSOCIATED WITH THE ADHESIVE. THE PATIENT EXPERIENCED PAIN AT THE SITE, WHICH RESOLVED AFTER THE SENSOR WAS REMOVED. THE BLISTERS HEALED WITHIN TWO DAYS WITHOUT POPPING. THE FINGER HEALED COMPLETELY, AND NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Angioedema; Discomfort; Skin Inflammation/ Irritation

  MAUDE report 22919377 ↗
• MalfunctionOct 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR'S ADHESIVE TORE OFF SOME OF THE PATIENT'S SKIN AND LEFT THE FINGER QUITE RED, IT WAS NOTED FOR 24 HOURS. THE CUSTOMER WAS PROVIDED WITH THE INSTRUCTION FOR USE (IFU) OF THE SENSOR, WHICH MUST BE CHANGED OR SWAPPED IN EIGHT HOURS AS TROUBLESHOOTING.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 20368923 ↗
• MalfunctionOct 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR'S ADHESIVE CAUSED SKIN INTEGRITY AND WAS NOTED FOR 24 HOURS. THE CUSTOMER WAS PROVIDED WITH THE INSTRUCTION FOR USE (IFU) OF THE SENSOR, WHICH MUST BE CHANGED OR SWAPPED IN EIGHT HOURS AS TROUBLESHOOTING.

  Patient problems: Insufficient Information

  MAUDE report 20368658 ↗
• MalfunctionFeb 29, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR HAD 6% + DIFFERENCE LOWER READING THAN ANOTHER SENSOR AFTER BEING SWAPPED OUT. THE CUSTOMER WAS ADVISED TO CHECK FOR PLACEMENT, LED LIGHTING AND MOVEMENT OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806197 ↗
• MalfunctionFeb 3, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE SENSOR HAD AN INACCURATE READING WHEN PLACE ON A PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637178 ↗
• MalfunctionFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE SHOWED INACCURATE READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636441 ↗
• MalfunctionFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE UNIT HAD INACCURATE READINGS WHEN PLACED ON A PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635799 ↗
• MalfunctionFeb 2, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN INACCURATE READINGS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635637 ↗
• MalfunctionDec 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT HAD PRESSURE ULCER. THE PATIENT'S HANDS WERE SWOLLEN AFTER USING THE DEVICE.

  Patient problems: Ulcer

  MAUDE report 18338538 ↗
• MalfunctionJun 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR CAUSED SEVERE RASH, BLISTERING AND SWELLING ON BOTH INDEX FINGERS. AFTER 24-48 HOURS, THE INDEX FINGER ON THE PATIENT'S LEFT HAND DEVELOPED A RASH. BECAME ITCHY AND BEGAN TO BLISTER, THE SENSOR WAS MOVED TO THE RIGHT FINGER AND THE SAME ISSUE OCCURRED. TOPICAL HYDROCORTISONE CREAM WAS APPLIED TO THE SITES. IN ADDITION, IT WAS FIRST AND SECOND DEGREE BURN, PATIENT WAS IN SUPINE POSITION. ATTENDING NURSE WHO APPLIED THE SENSOR AND SKIN INTEGRITY WAS VISIBLE SINCE SEVERE ITCHING ALERTED PERSONNEL TO THE ISSUE. PATIENT WAS STABLE.

  Patient problems: Burn(s)

  MAUDE report 17139632 ↗
• MalfunctionNov 15, 2021Human-Device Interface Problem; Patient Device Interaction Problem; Human-Device Interface Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD THE SENSOR WHEN MRI WAS DONE AND THE PATIENT FELT HER MIDDLE FINGER WAS HOT. THE PATIENT HAD THE SENSOR FOR SEVERAL MINUTES AND WAS REMOVED DUE TO THE PATIENT'S FEEDBACK. NO INJURY WAS NOTED WHEN THE SENSOR WAS REMOVED. THE PATIENT WAS ASSESSED BY THE WOUND OSTOMY STAFF THE NEXT DAY AND THERE WAS NO REDNESS OR SWELLING FOUND. THE CUSTOMER WAS ADVISED THAT THE SENSOR SHOULD NOT BE PLACED IN MRI AS IT MAY CAUSE BURNS, INACCURATE READINGS AND ARTICRAFT IN MRI IMAGES.

  Patient problems: Burn(s)

  MAUDE report 12817725 ↗
• InjuryDec 23, 2020Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, THE SENSOR HAD A FAILURE. IT WAS INDICATED THAT THE O2 SENSOR WAS REPORTING NORMAL O2 SAT ON MONITOR, BUT (ABG) ARTERIAL BLOOD GAS SHOWED HYPOXEMIA. THE O2 SENSOR WAS CHANGED THEN THE O2 SAT REFLECTED ABG RESULT. IT WAS INDICATED THAT THEY COMPARED READINGS FOR SENSOR WITH ARTERIAL BLOOD GAS AND THEN SWAPPED SENSOR TO ISOLATE TO THE SENSOR BEING THE PROBLEM. THE PATIENT EXPERIENCED HYPOXEMIA.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11064412 ↗
• MalfunctionSep 27, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READINGS THAT DID NOT CORRELATE TO PATIENT'S BLOOD GASSES. IT WAS STATED THAT PATIENT WAS GETTING NORMAL SAT READINGS AND ABRUPTLY DROPPED TO 60S AND 70S WHICH LED TO OVER TREATING PATIENT. THEY SWAPPED THE SENSORS, CABLES AND MULTI MEASUREMENT SERVERS WITH NO CHANGE. THE SPO2 WAS LOW COMPARED TO ABG'S USING OTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131695 ↗
• MalfunctionSep 27, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READINGS THAT DID NOT CORRELATE TO PATIENT'S BLOOD GASSES. IT WAS STATED THAT PATIENT WAS GETTING NORMAL SAT READINGS AND ABRUPTLY DROPPED TO 60S AND 70S WHICH LED TO OVER TREATING PATIENT. THEY SWAPPED THE SENSORS, CABLES AND MULTI MEASUREMENT SERVERS WITH NO CHANGE. THE SPO2 WAS LOW COMPARED TO ABG'S USING OTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131682 ↗
• MalfunctionSep 27, 2019Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READINGS THAT DID NOT CORRELATE TO PATIENT'S BLOOD GASSES. IT WAS STATED THAT PATIENT WAS GETTING NORMAL SAT READINGS AND ABRUPTLY DROPPED TO 60S AND 70S WHICH LED TO OVER TREATING PATIENT. THEY SWAPPED THE SENSORS, CABLES AND MULTI MEASUREMENT SERVERS WITH NO CHANGE. THE SPO2 WAS LOW COMPARED TO ABG'S USING OTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131664 ↗
• MalfunctionJun 17, 2019High Readings; High Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD ERRATIC READINGS. FROM THE TEXT, IT SHOWED SPO2 AT 89 BUT THE SENSOR READ 95%. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704373 ↗
• MalfunctionJan 18, 2019High Readings; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD READING ISSUE. IT WAS REPORTED THAT THE DEVICE HAD A HIGH SPO2 READING, BUT AN ARTERIAL BLOOD GAS REPORTED A PO2 OF 31MMHG AND AN SAO2 OF 47%. IT WAS STATED THAT INCORRECT PROBE WAS USED DURING THE INCIDENT. THE CUSTOMER REPORTED THAT PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Information

  MAUDE report 8262185 ↗
• MalfunctionMay 24, 2018False Reading From Device Non-Compliance; False Reading From Device Non-Compliance

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE ON THE PATIENT, SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION) WAS ALARMING, THE PULSE OXIMETRY WAS IN THE 70¿S IN PARENTHESIS AND GOOD WEIGHT FORM. THE PATIENT WAS IN BED FOR 5 DAYS WITH SPO2 FORM RANGING 90% TO 100%. A NEW SENSOR WAS PLACED ON THE PATIENT AND PRIOR ONE HAD FALLEN OFF AT 1400 DEGREES. THE MONITOR ALARMED WITH GOOD WEIGHT FORM AND PATIENT WAS ON RESPIRATORY DISTRESS AND NEW SENSOR READ 100% WITH SAME WEIGHT FORM WITH FAULTY ONE. THERE WAS PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Respiratory Distress

  MAUDE report 7542302 ↗

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.