HemoSphere HEM1Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00690103197006), received between May 10, 2021 and Jan 29, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (46 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 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, THE HEMOSPHERE 1 MONITOR DISPLAYED ERRONEOUS VALUES WHILE CONNECTED TO THE FLOTRAC DEVICE. THE TROUBLESHOOTING STEPS TAKEN AT THE TIME OF THE EVENT ARE UNKNOWN. BIOMEDICAL ENGINEERING ALSO NOTED THAT THE UNIT HAS A HEMOSPHERE SWAN-GANZ MODULE LODGED INSIDE, AND THE RELEASE BUTTON APPEARS TO BE JAMMED. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM ASSOCIATED WITH THIS REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210498 ↗
• MalfunctionJan 8, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, BEFORE USE, THE HEMOSPHERE 1 MONITOR WAS NOT GIVING CORRECT CO NUMBERS. THE CLINICIAN CHANGED CABLES WITHOUT RESOLVE. A NEW MONITOR WORKED AS EXPECTED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011497 ↗
• MalfunctionJan 8, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, BEFORE USE, THE HEMOSPHERE 1 MONITOR WAS NOT GIVING CORRECT CO NUMBERS. THE CLINICIAN CHANGED CABLES WITHOUT RESOLVE, NEW MONITOR WORKED AS EXPECTED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24011175 ↗
• MalfunctionDec 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THIS HEMOSPHERE MONITOR, IT WAS SUSPECTED OF PROVIDING INCORRECT SVR. THE CABLE WAS TRIED ON ANOTHER MONITOR AND WORKED. SWITCHING OUT THE MONITOR FOR ANOTHER MONITOR CORRECTED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855967 ↗
• MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE HEMOSPHERE MONITOR, AN SVO2 ERROR MESSAGE APPEARED AND IT WOULD NOT GIVE CORRECT CO NUMBERS. THE USER TRIED TO CHANGE THE CABLES TO RESOLVE THE ISSUE BUT IT DID NOT WORK. A NEW MONITOR WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749475 ↗
• MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE HEMOSPHERE MONITOR, AN SVO2 ERROR MESSAGE APPEARED AND IT WOULD NOT GIVE CORRECT CO NUMBERS. THE USER TRIED TO CHANGE THE CABLES TO RESOLVE THE ISSUE BUT IT DID NOT WORK. A NEW MONITOR WORKED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749457 ↗
• MalfunctionJun 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE 1 MONITOR EXPERIENCED CONSISTENTLY LOW MEAN ARTERIAL PRESSURE (MAP) V. SIMULTANEOUS NON-INVASIVE BLOOD PRESSURE (NIBP). IT WAS CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321655 ↗
• MalfunctionMay 30, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WHEN CONNECTING THIS HEMOSPHERE MONITOR TO THE PATIENT, THE SVI (STROKE VOLUME INDEX) READINGS WERE HIGH (AROUND 88ML/M2/BEAT) WHILE THE EXPECTED VALUE WAS ABOUT 20ML/M2/BEAT). AS TROUBLESHOOTING, THE CABLES WERE CHANGED AND THE CONNECTIONS WERE CHECKED, BUT THE PROBLEM CONTINUED. TO SOLVE THE ISSUE, THE MONITOR WAS REPLACED WITH A DIFFERENT ONE. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112759 ↗
• MalfunctionMay 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, DURING USE, A HEMOSPHERE MONITOR STOPPED PROVIDING ARTERIAL PRESSURE-BASED CARDIAC OUTPUT, DISPLAYED A "FAULT: PRESSURE CABLE" ERROR MESSAGE, AND HAD A DISCREPANCY WITH THE CENTRAL VENOUS PRESSURE (CVP) VALUES. CVP VALUES WERE OBTAINED THROUGH ANALOG INPUT AND DISPLAYED ON THE PATIENT MONITOR. THERE WAS NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952801 ↗
• MalfunctionApr 24, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE IN PATIENT, THE CENTRAL VENOUS PRESSURE (CVP) AND MEAN ARTERIAL PRESSURE (MAP) VALUES OF THIS HEMOSPHERE MONITOR WERE DIFFERENT FROM THE VALUES FROM THE PHILIPS MONITOR (ANALOG INPUT). THE ISSUE WAS SOLVED BY ADJUSTING THE VOLTAGE RANGE CONFIGURATION. PATIENT DEMOGRAPHICS HAVE BEEN REQUESTED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE THE ISSUE WAS SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901120 ↗
• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMOSPHERE MONITOR IS GIVING INCORRECT SVO2 VALUES THAT DO NOT CORRELATE WITH THE PATIENT CONDITION OR LAB WORK. THE STAFF RECALIBRATED AND EXCHANGED OUT CABLES WITH NO RESOLVE. THEY EXCHANGED TO A NEW HEMOSPHERE MONITOR WITH THE SAME CABLES AND THE SVO2 VALUES WERE CORRECT. THIS WAS DURING USE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862122 ↗
• MalfunctionMar 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE VALUES THAT DISPLAYED DURING PATIENT USE WITH A HEMOSPHERE MONITOR. THE BLOOD PRESSURE READING ON THE HEMOSPHERE WAS DISPLAYING AS 99/38 AND THE PHILIPS BEDSIDE UNIT WAS DISPLAYING AS 109/42. THE DISPLAYED NUMBERS WERE DIFFERENT THROUGHOUT THE CASE. THE PROCEDURE WAS AN EMBOLIZATION CASE. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624723 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, A HEMOSPHERE MONITOR DISPLAYED INACCURATE PRESSURE VALUES. THE MONITOR WAS ON A SALES REP AND SHOWED A SYSTOLIC BLOOD PRESSURE THAT WAS 90-100MMHG ABOVE THE EXPECTED VALUES. THERE WERE NO PATIENT INJURIES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597610 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE, A HEMOSPHERE MONITOR DISPLAYED INACCURATE PRESSURE VALUES. THE CABLE AND SWAN GANZ MODULE WERE EXCHANGED, BUT THE ISSUE CONTINUED. THE ISSUE WAS RESOLVED BY EXCHANGED THE MONITOR. THERE WERE NO PATIENT INJURIES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595044 ↗
• MalfunctionFeb 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A HEM1 SHOWED MODERATE AND SEVERE VASOCONSTRICTION AND LOW STROKE VOLUME DURING USE ON A SALES REP. ISSUE OCCURRED DURING DEMONSTRATION ON SALES REP. NO PATIENTS WERE INVOLVED. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446887 ↗
• MalfunctionFeb 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, DURING USE OF THE HEM1, THE CO/CI VALUES WERE LOW COMPARED TO THOSE ON A DIFFERENT MONITOR. THE NURSE CHANGED THE HEM1, KEPT THE CABLE AND THE MODULE ATTACHED TO THE SWAN-GANZ CATHETER AND THE NEW MONITOR SHOWED MORE NORMAL VALUES THAT MORE ACCURATELY REFLECTED THE PATIENT'S CONDITION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364939 ↗
• MalfunctionFeb 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, THAT DURING USE WITH THIS HEMOSPHERE MONITOR, THAT THE CENTRAL VENOUS PRESSURE (CVP) WAS DOUBLED IN VALUE. THE USER CONFIRMED THAT THE MAP AND CVP WERE NOT CROSSED, ANALOG CABLES WERE CHANGED, AND THE MONITOR WAS BROUGHT TO A DIFFERENT ROOM AND CONNECTED TO A DIFFERENT BEDSIDE MONITOR BUT THE ISSUE CONTINUED. THERE WAS NO ALLEGATION OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300042 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING USE WITH PATIENT, THERE WAS A DIFFERENCE IN MAP (MEAN ARTERIAL PRESSURE) VALUES BETWEEN THIS HEMOSPHERE MONITOR (36 MMHG) AND PHILIPS BED SITE MONITOR (72 MMHG). NO ERROR MESSAGE WAS DISPLAYED. AFTER REPLACING THE HEMOSPHERE WITH ANOTHER ONE THE MAP CORRELATED. THE PATIENT WAS NOT INJURED OR TREATED INCORRECTLY. AS PER SUGGESTED TROUBLESHOOTING, THE VOLTAGE RANGE SETTINGS WERE DIFFERENT WHEN COMPARED WITH ANOTHER MONITOR. ONCE VOLTAGE RANGE SETTINGS WERE CHANGED TO THE CORRECT ONES, THE MAP VALUES WERE THE SAME ON BOTH MONITORS. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, SINCE THE ISSUE COULD BE SOLVED WITH TROUBLESHOOTING. PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742728 ↗
• MalfunctionOct 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMOSPHERE WAS NOT TRANSMITTING THE SAME PATIENT PARAMETER PRESSURE NUMBERS THAT THE GE BEDSIDE MONITOR WAS RECEIVING. THE CLINICIAN STATED THE NUMBERS DID NOT CORRELATE TO THE ARTERIAL BLOOD PRESSURE NUMBERS DISPLAYING ON THE GE BEDSIDE MONITOR. THIS OCCURRED FOR SEVERAL MINUTES. THE HEMOSPHERE READ MID 80S SYSTOLIC WITH THE MEAN ARTERIAL PRESSURE IN THE MID TO LOW 60S. THE GE MONITOR WAS SHOWING THE ARTERIAL WAVEFORM FROM CLEARSIGHT IN THE LOW 100 TO 119 SYSTOLIC AND THE MEAN ARTERIAL PRESSURE IN THE 70S. AFTER THE CLINICIAN RE-ZEROED, THE BEDSIDE MONITOR ARTERIAL WAVEFORM DID CORRELATE WITH THE HEMOSPHERE UNIT DISPLAY FOR THE SYSTOLIC BLOOD PRESSURE IN THE MID 80S AND THE MEAN ARTERIAL PRESSURE IN THE MID TO LOW 60S. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY. THERE WAS NO INAPPROPRIATE TREATMENT ADMINISTERED. THERE IS NO PRODUCT RETURN AS THE USER DID NOT RECORD THE SERIAL NUMBER OF THE SUSPECT UNIT. IT IS UNKNOWN WHICH UNIT IS SUSPECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417058 ↗
• MalfunctionOct 10, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED, DURING USE, THAT A HEM1 MONITOR DISPLAYED CO NUMBERS THAT WERE PRESUMED TO BE WRONG. DUE TO ISSUE, CUSTOMER STOPPED USING THE MONITOR. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416778 ↗
• MalfunctionOct 3, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WITH THIS HEMOSPHERE MONITOR THE MIXED VENOUS OXYGEN SATURATION (SVO2) VALUES DRIFTED FROM 48% TO 72%. A SOFTWARE ISSUE WAS ALSO OBSERVED, HOWEVER, NO FURTHER DETAILS WERE PROVIDED. IT IS UNKNOWN IF ANY ERROR MESSAGE WAS DISPLAYED, BUT NO ERROR MESSAGE WAS FOUND REVIEWING THE LOGS. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357560 ↗
• MalfunctionOct 3, 2024Incorrect Measurement; Incorrect Measurement

  AS REPORTED, WHEN USING CENTRAL VENOUS PRESSURE (CVP) VALUE TRANSFERRED FROM MINDRAY MONITOR, THIS HEMOSPHERE MONITOR PROVIDED HIGH SYSTEMIC VASCULAR RESISTANCE (SVR) VALUE. OTHER MINDRAY ANALOG CABLES WERE TESTED WITHOUT SUCCESS. ENTERING MANUALLY THE CVP VALUE PROVIDED CORRECT SVR PARAMETER. NO FURTHER INFORMATION AVAILABLE. 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 20357488 ↗
• MalfunctionAug 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WERE INACCURATE VALUES WITH THE HEMOSPHERE MONITOR DURING PATIENT USE. THE CARDIAC OUTPUT NUMBERS THAT DISPLAYED ON THE UNIT WERE INACCURATE COMPARED TO THE CARDIAC OUTPUT NUMBERS FROM THE BLOOD DRAW. THE CARDIAC OUTPUT NUMBER WAS APPROXIMATELY 4 THROUGHOUT THE SURGERY. ON ARRIVAL TO THE SURGICAL INTENSIVE CARE UNIT THE CARDIAC NUMBER WAS LESS THAN 2. THE CLINICIANS CHECKED THE PATIENT HEIGHT AND WEIGHT AND DEMOGRAPHIC INFORMATION THAT WAS ENTERED TO CONFIRM IT WAS CORRECT. THEY DID A FICK AND THE CARDIAC OUTPUT RESULTS WERE BETWEEN 3 AND 4. THEY CONVERTED THE SWAN CATHETER TO MANUAL THERMODILUTION AND THE RESULTS WERE 3 TO 4. THEY PERFORMED A CABLE TEST ON THE CABLE AND IT PASSED THE TEST. THEY EXCHANGED FOR A DIFFERENT HEMOSPHERE UNIT AND THE CARDIAC OUTPUT RESULTS WERE NOW BETWEEN 3 AND 4. THERE WAS NO INAPPROPRIATE PATIENT TREATMENT ADMINISTERED. THE PATIENT DEMOGRAPHICS WERE REQUESTED AND ARE NOT AVAILABLE. THE PATIENT HAS BEEN DISCHARGED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19986728 ↗
• MalfunctionAug 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEART RATE WAS NOT DISPLAYED ON THE HEMOSPHERE MONITOR, OR IT WAS DISPLAYING HEART RATE BUT SHOWING UNSTABLE VALUES SUCH AS 7 BPM OR 14 BPM. THE EXPECTED HR VALUES WERE BETWEEN 70 BPM AND 90 BPM, SIMILAR TO THOSE SHOWN BY THE PATIENT MONITOR. THERE WAS NO ABNORMALITY FOUND IN THE WAVEFORM AND IT MATCHED TO THE PRESSURE VALUE. THE ERROR MESSAGE, ALERT SV HEART RATE SIGNAL MISSING, WAS DISPLAYED IN THE SITUATION THAT HR VALUES WERE NOT DISPLAYED. THE ISSUE WAS NOT CONSIDERED TO BE AFFECTED BY THE PATIENT CONDITION. THE ANALOG CABLE WAS REPLACED, BUT NO IMPROVEMENT WAS OBSERVED. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE INACCURATE VALUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940379 ↗
• MalfunctionAug 8, 2024Incorrect Measurement; Appropriate Device Problem Term/Code Not Available; Incorrect Measurement; Appropriate Device Problem Term/Code Not Available

  AS REPORTED, DURING USE IN PATIENT WITH THIS HEMOSPHERE (HS) MONITOR, THERE WAS A DIFFERENCE IN THE CVP DISPLAYED WHEN COMPARED TO THE BEDSIDE MONITOR (19MMHG VS. 17MMHG). NO ERROR MESSAGE WAS DISPLAYED. TROUBLESHOOTING WAS PERFORMED WITH TECH SUPPORT BUT THE ISSUE WAS NOT SOLVED. LATER ON, SALES REP VISITED THE HOSPITAL AND THE ISSUE WAS SOLVED, THE EXACT TROUBLESHOOTING PERFORMED IS UNKNOWN. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938085 ↗