HemoSphere AltaRecalls & reported problems across all models

We found 3 models of HemoSphere Alta by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2024 and Mar 17, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported HemoSphere Alta problems

HemoSphere Alta models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• HemoSphere Alta ALTAALL1

  Catheter, Oximeter, Fiber-Optic
  22 reports
• HemoSphere Alta ALTACR1

  Catheter, Oximeter, Fiber-Optic
  3 reports
• HemoSphere Alta ALTASR1

  Catheter, Oximeter, Fiber-Optic
  2 reports

Recent HemoSphere Alta adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026High Readings

  AS REPORTED, DURING USE IN A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION PROCEDURE OF THIS HEMOSPHERE ALTA MONITOR CONNECTED TO A SWAN-GANZ IQ CATHETER, THE RIGHT VENTRICLE CARDIAC OUTPUT (RVCO) VALUES OF 7.3 L/MIN PROVIDED WERE INCONSISTENT WITH PATIENT'S CLINICAL CONDITION. THEN, A BOLUS THERMODILUTION WAS PERFORMED, OBTAINING AN INTERMITTENT CARDIAC OUTPUT (ICO) VALUE OF 4.3 L/MIN. THE FOLLOWING DAY, RVCO WAS RECALIBRATED, AND THE VALUES WERE ALIGNED (RVCO = 3.8 L/MIN; ICO = 3.7 L/MIN). RVCO REMAINED RELIABLE AFTER THIS CALIBRATION. THERE WERE NO CONSEQUENCES FOR PATIENT, AS PHYSICIAN JUDGEMENT WAS USED TO GUIDE THERAPY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615913 ↗
• MalfunctionFeb 27, 2026Incorrect Measurement

  AS REPORTED, DURING USE THIS HEMOSPHERE ALTA MONITOR WITH A SWAN GANZ CATHETER, UNSTABLE CENTRAL VENOUS PRESSURE (CVP) WAS PROVIDED (SEE IMAGES ATTACHED). IN ADDITION, VENTRICULAR STROKE VOLUME INDEX (VTDI) WAS NOT PROVIDED. AS PER CUSTOMERS OPINION THE ISSUE WAS CAUSED BY THE CATHETER NOT BEING POSITIONED CORRECTLY. THE PATIENT WAS NOT IN ATRIAL FIBRILLATION AND DID NOT HAVE ANY ARRHYTHMIAS. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466644 ↗
• MalfunctionFeb 12, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE HEMOSPHERE ALTA MONITOR EXPERIENCED SIGNIFICANT MEAN ARTERIAL PRESSURE (MAP) VARIABILITY WHEN USING CLEARSIGHT. SPECIFICALLY, ARTERIAL LINE CORRELATION DRIFTING BY 20 TO 40 MMHG. IT WAS ALSO NOTED THAT THE SUSPECT DEVICE EXPERIENCED FAULT: CLEARSIGHT SYSTEM AIR SUPPLY ERROR AND INSUFFICIENT PRESSURE BUILD UP. THERE ARE NO ALLEGATIONS OF PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328911 ↗
• MalfunctionFeb 4, 2026Low Readings

  AS REPORTED, DURING A LIVER TRANSPLANT PROCEDURE IN A HYPERDYNAMIC PATIENT, THE HEMOSPHERE ALTA MONITOR CONNECTED TO A SWAN-GANZ IQ CATHETER DISPLAYED RIGHT VENTRICLE CARDIAC OUTPUT (RVCO) AROUND 3 L/MIN, ASSESSED AS LOW COMPARED TO INTERMITTENT CARDIAC OUTPUT (ICO), WHICH WAS 6 L/MIN. INTERMITTENT CO MEASUREMENTS WERE MORE CLINICALLY CONSISTENT WITH THE PATIENT'S CONDITION. RIGHT VENTRICLE PRESSURE WAVEFORM AND SWAN-GANZ CATHETER POSITION WERE CONSIDERED CORRECT. THE SAME ISSUE OCCURRED IN THE INTENSIVE CARE UNIT (ICU) THE FOLLOWING DAY WITH THE SAME PATIENT. PATIENT MANAGEMENT WAS GUIDED BY THE VALUES DEEMED MOST CLINICALLY APPROPRIATE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION. PATIENT DEMOGRAPHIC INFORMATION WAS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256442 ↗
• MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ALTA CARDIAC MONITOR THE BLOOD TEMPERATURE WAS INCORRECT. THERE WAS NO ALERT OR ERROR MESSAGE FROM THE MONITOR. THE MONITOR WAS DISPLAYING TEMPERATURES OF 89 TO 91 DEGREES. AT THAT POINT IT WAS NOT CALCULATING CO VALUES EITHER. THE REP FIRST REPLACED THE CCO CABLE IN AN ATTEMPT TO TROUBLESHOOT, HOWEVER THE MONITOR AGAIN READ LOW TEMPERATURE WITH NO ALERT BUT WAS CALCULATING CO NUMBERS. TEMPERATURES WERE CONFIRMED BY FOLEY CATHETER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835470 ↗
• MalfunctionNov 26, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRIOR TO USE, THE HEMOSPHERE ALTA SYSTEM WITH CLEARSIGHT DISPLAYED A SUBSYSTEM FAILURE ALERT. THE END USER RESTARTED THE DEVICE AND CLEARED THE ALERT; HOWEVER, SUBSEQUENT MEASUREMENTS SHOWED VARIATIONS IN BLOOD PRESSURE (BP) AND PULSE RATE (PR). THE ISSUE COULD NOT BE RESOLVED EVEN AFTER REPLACING THE PC2K MODULE. ADDITIONAL FOLLOW-UP EFFORTS HAVE FOCUSED ON DETERMINING PATIENT INVOLVEMENT AND WHETHER ANY INJURY OR HARM OCCURRED AS A RESULT OF THE REPORTED EVENT. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659549 ↗
• MalfunctionNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WERE INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY HAS OCCURRED REPEATEDLY SEVERAL TIMES PER DAY ACROSS MULTIPLE CASES AND APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THERE WERE NO ALLEGATIONS OF PATIENT INJURIES. ISSUE OCCURRED AT OTHER HOSPITALS. FURTHER INFORMATION WAS NOT PROVIDED. IT IS UNKNOWN HOW MANY HOSPITALS AND MONITORS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589476 ↗
• MalfunctionNov 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, THE BLOOD PRESSURE (BP) READINGS OBTAINED FROM AN ALTA MONITOR WAS SIGNIFICANTLY INCONSISTENT AND NOT CORRELATING WITH THE NON-INVASIVE BLOOD PRESSURE CUFF OR INVASIVE ARTERIAL LINE. MEAN ARTERIAL PRESSURE (MAP) VALUES, SYSTOLIC, AND DIASTOLIC VALUES WERE OFTEN VASTLY INACCURATE, EITHER MUCH HIGHER OR LOWER. PER REPRESENTATIVE, "THIS DISCREPANCY APPEARS TO RESOLVE ONLY WHEN THE PATIENT MONITOR IS ZEROED BEFORE ACUMEN IQ FINGER CUFF APPLICATION." THE FOLLOWING TROUBLESHOOTING WAS COMPLETED: VERIFIED CORRECT PATIENT CONNECTION AND PROPER CUFF PLACEMENT PER IFU, RECONNECTED FINGER CUFF AND RESTARTED THE MONITOR, COMPARED ACUMEN IQ READINGS TO NIBP AND/OR A-LINE READINGS, AND OBSERVED THAT ZEROING THE PATIENT MONITOR PRIOR TO CONNECTING IMPROVES CORRELATION TEMPORARILY WITH THE ALTA MONITOR. THERE WERE NO ALLEGATIONS OF PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589333 ↗
• MalfunctionOct 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE ALTA ALL IN ONE, AN UNPROMPTED HIGH-PITCHED ALARM OCCURRED DURING THE CASE. THE TOUCHSCREEN FROZE, ARTERIAL LINE PRESSURE DISAPPEARED FROM THE ANESTHESIA MONITOR, AND SVO2 READ APPROXIMATELY 30 POINTS LOWER THAN EXPECTED. REBOOTING THE MONITOR RESTORED FUNCTION, BUT THE SVO2 READING REMAINED INACCURATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352285 ↗
• MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, DURING USE, AN ALTA MONITOR DISPLAYED INACCURATE CARDIAC OUTPUT, STROKE VOLUME, CENTRAL VENOUS PRESSURE, STO2, AND SYSTEMIC VASCULAR RESISTANCE VALUES. THE MONITOR ALERTS WERE NOT AUDIBLE EVEN THOUGH IT WAS ACTIVATED IN THE SETTINGS AND NO ALERTS WERE DISPLAYED. ISSUE WAS RESOLVED BY RESTARTING THE MONITOR. THERE WERE NO ALLEGATION OF PATIENT INJURIES. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856503 ↗
• MalfunctionAug 8, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A TRICUSPID VALVE AND MITRAL VALVE RECONSTRUCTION WITH LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE OF THIS HEMOSPHERE ALTA MONITOR, THE SECOND TIME THE ICO AND CORV WERE MEASURED, THE ICO WAS 3.4 AND THE CORV 1.8. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22747835 ↗
• MalfunctionAug 6, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A MITRAL VALVE REPLACEMENT WITH PSEUDOANEURYSM CASE, THE TOTAL HEMOGLOBIN (THB) VALUE WAS HIGHER (10.7 G/DL) ON THE HEMOSPHERE ALTA MONITOR WHEN COMPARED TO THE VALUE OBTAINED FROM THE BLOOD GAS SAMPLE (7.9 G/DL). THE VALUES TREND REMAINED STRAIGHT AND CONSTANT DURING THE WHOLE PROCEDURE EVEN IF THE SENSOR MAY NOT STICK PERFECTLY. AFTER RECALIBRATING THE MONITOR, THB VALUES MATCHED TO THE ONES PROVIDED BY THE BLOOD GAS. THERE WAS NO ERROR MESSAGE DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES. THERE WAS NO PATIENT MOVEMENT. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727685 ↗
• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A LVAD- HEARTMATE PROCEDURE, THE SCREEN OF THIS HEMOSPHERE ALTA MONITOR FAILED AS THE DPDT VALUE WAS SIGNIFICANTLY DIFFERENT FROM THE ALTA MONITOR THAN FROM THE ECHO. ALSO, AFTER BYPASS, THE ICO (1.6) WAS LOWER THAN THE CORV (3.0). AFTER CALIBRATION, THE ICO WAS MORE STABLE. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE MONITOR WILL NOT BE RETURNED AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673571 ↗
• MalfunctionJul 31, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS TARGET MARKET RELEASE (TMR) ON A MITRAL VALVE & TRICUSPID VALVE REPLACEMENT PROCEDURE, THIS HEMOSPHERE ALTA MONITOR DISPLAYED A MUCH HIGHER ICO (INTERMITTENT CARDIAC OUTPUT) (3.1) THAN CORV (CARDIAC OUTPUT RIGHT VENTRICLE) (2.1). IN ADDITION, THE RV DP/DT VALUE WAS MUCH LOWER (200) THAN ECHO ON THE TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) (700). MOREOVER, IN NON-PULSATILE MODE, THE CEREBRAL ADAPTATIVE INDEX (CAI) WAS INTERMITTENTLY AND INCONSISTENTLY HIGHER THAN 45 NOT DEPENDING ON PROCEDURE, ALTHOUGH MOST OF THE TIME WAS BELOW 45. THERE WAS NO ERROR MESSAGES DISPLAYED. THE PATIENT WAS NOT TREATED ACCORDING TO THE INACCURATE VALUES PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673544 ↗
• MalfunctionJul 14, 2025Incorrect Measurement; Incorrect Measurement

  AS REPORTED, DURING THIS ALTA TARGET MARKET RELEASE (TMR) USING A SWAN-GANZ IQ CATHETER, THE DPDT RV VALUE (111 MMHG/S) WAS MUCH LOWER THAN THE DPDT OBTAINED USING THE ECHO TO GRAPH THE WAVEFORM OF THE RV (699 MMHG/S). THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN AS THIS IS A TMR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493448 ↗

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