HemoSphere HEMOXSC100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103196986), received between Jul 13, 2021 and May 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (8 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 2, 2017Terminated

   Pre-procedural issues related to software defects

   Z-0496-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN OXIMETRY CABLE WAS NOT GIVING APPROPRIATE READINGS. ISSUE WAS RESOLVED BY USING A NEW CABLE. THERE WERE NO DAMAGES AND NO PATIENT HARM. FURTHER INFORMATION NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080123 ↗
• MalfunctionApr 3, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WHEN CONNECTING THE HEMOSPHERE OXIMETRY CABLE TO THE PATIENT, THE SVO2 (MIXED VENOUS OXYGEN SATURATION) VALUES WERE 20 HIGHER THAN EXPECTED. THE VALUES WERE COMPARED WITH A BLOOD GAS ANALYSIS (ABG) THAT INDICATED A VALUE OF 50, WHILE THE HEMOSPHERE OXIMETRY CABLE SHOWED A VALUE OF 70%. THE CABLE WAS REPLACED WITH ANOTHER ONE, AND THE VALUES OBTAINED WERE CORRECT. NO FURTHER INFORMATION AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759638 ↗
• MalfunctionFeb 7, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WHEN CLAMPING AND UNCLAMPING THE VENOUS CAVA, THIS HEMOSPHERE OXIMETRY CABLE PROVIDED CORRECT AND UPDATED CI AND BP VALUES, HOWEVER THE MIXED VENOUS OXYGEN SATURATION (SVO2) PARAMETER DID NOT UPDATE ACCORDINGLY SHOWING INCORRECT VALUES NOT CORRESPONDING TO THE PHYSIOLOGICAL STATUS OF THE PATIENT. PATIENT DEMOGRAPHICS HAVE BEEN REQUESTED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21330773 ↗
• MalfunctionJan 10, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS HEMOSPHERE OXIMETRY CABLE PROVIDED DIFFERENT MEASUREMENTS THAN EXPECTED ACCORDING TO PHYSIOLOGICAL STATE OF THE PATIENT. THE ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122449 ↗
• MalfunctionJan 10, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, THIS HEMOSPHERE OXIMETRY CABLE PROVIDED DIFFERENT MEASUREMENTS THAN EXPECTED ACCORDING TO PHYSIOLOGICAL STATE OF THE PATIENT. THE ISSUE WAS SOLVED REPLACING THE DEVICE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21122425 ↗
• MalfunctionNov 27, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED BEFORE USE THAT THE END USER DIDN'T LIKE THE NUMBERS BEING PRODUCED. THE TROUBLESHOOTING STEPS ARE UNKNOWN. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20793909 ↗
• MalfunctionNov 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE HEMOSPHERE OXIMETRY CABLE DURING PATIENT USE. THE BIOMED STATED IT WAS GIVING INACCURATE READINGS. THE NUMBERS THAT DISPLAYED AND WHAT THE NUMBERS WERE EXPECTED TO BE IS UNKNOWN. WHEN THE CLINICIAN EXCHANGED FOR A KNOWN WORKING OXIMETRY CABLE, USING THE SAME MONITOR AND ACCESSORIES, THEN EVERYTHING WORKED. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT HARM OR INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED, BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729232 ↗
• MalfunctionNov 11, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT INACCURATE SCVO2 VALUES WERE OBSERVED DURING USE. THE ISSUE WAS RESOLVED BY REPLACING THE CABLE. NO TREATMENT WAS PERFORMED BASED ON THE INCORRECT VALUES. THEY ATTEMPTED TO OBTAIN INFORMATION SUCH AS INDICATED VALUE, EXPECTED VALUE, DATA LOG, WHETHER ANY ERROR MESSAGE WAS DISPLAYED OR WHETHER THE VALUES WERE AFFECTED BY THE PATIENT CONDITION, BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20656076 ↗
• MalfunctionJul 22, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT OF THIS OXIMETRY CABLE, VALUES FLUCTUATED BETWEEN 1% AND 55%. NO ERROR MESSAGE WAS DISPLAYED. THE CABLE WAS CALIBRATED SEVERAL TIMES, BUT THE ISSUE REMAINED. PATIENT WAS NOT TREATED ACCORDING THE INCORRECT VALUES DISPLAYED. REPLACING THE CABLE FOR ANOTHER ONE, THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790495 ↗
• MalfunctionJun 3, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, AFTER SETTING UP THIS HEMOSPHERE MONITOR TO BE USED IN A POST CARDIAC SURGERY PATIENT, JUST AFTER CALIBRATE THIS HEMOSPHERE OXIMETRY CABLE, SVO2 VALUES PROMPTLY DROPPED FROM 55% TO 18% AND DID NOT CORRELATE WITH THE BLOOD GAS VALUES. THERE WAS NO ERROR MESSAGE WAS DISPLAYED. THE SWAN GANZ CATHETER WAS REPOSITIONED, AND THEN REPLACED FOR A NEW ONE BUT THE ISSUE REMAINED. CARDIAC OUTPUT AND PULMONARY ARTERY PRESSURE WORKED CORRECTLY ALL THE TIME. THEN A SECOND HEMOSPHERE MONITOR AND CABLES WERE USED AND THE ISSUE WAS SOLVED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445631 ↗
• MalfunctionJul 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMOXSC100 GENERATED INACCURATE NUMBERS. THE SVO2 WOULD RANDOMLY GO UP AND DOWN FROM THE 30S TO 60S WHICH DID NOT MATCH THE PATIENTS STABLE HEMODYNAMIC CONDITION. THE NURSE EXCHANGED THE SUSPECT HEMOXSC100 USING ALL THE SAME EQUIPMENT AND THE SVO2 NUMBERS WERE STABLE BETWEEN 64 AND 72. THERE WAS NO PATIENT INJURY OR INAPPROPRIATE TREATMENT ADMINISTERED DUE TO THE INACCURATE NUMBERS. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162757 ↗