HemoSphereRecalls & reported problems across all models

We found 6 models of HemoSphere by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 115 adverse event reports in the FDA's MAUDE database, received between May 10, 2021 and Sep 15, 2026 — classified as 3 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (80 reports).

1 FDA recall record name at least one of these models by its device 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. 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

HemoSphere recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 2, 2017Terminated

   Pre-procedural issues related to software defects

   Z-0496-2018 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

Most reported HemoSphere problems

HemoSphere models

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

• HemoSphere HEM1

  Catheter, Oximeter, Fiberoptic
  1 recall65 reports
• HemoSphere HEMOXSC100

  Catheter, Oximeter, Fiberoptic
  1 recall11 reports
• HemoSphere HEMSGM10

  Catheter, Oximeter, Fiberoptic
  1 recall5 reports
• HemoSphere HEMCSM10

  Computer, Diagnostic, Programmable
  29 reports
• HEMOSPHERE HEMPSC100

  Adjunctive Predictive Cardiovascular Indicator
  4 reports
• HEMOSPHERE HEMDPT1000

  Adjunctive Predictive Cardiovascular Indicator
  1 report

Recent HemoSphere adverse event reports

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

• MalfunctionSep 15, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during use of the Clearsight module the user kept getting inaccurate readings.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774306 ↗
• InjuryMay 18, 2026Patient Device Interaction Problem

  AS REPORTED FROM GERMANY BY OUR EDWARDS LIFESCIENCES AFFILIATES, HEART BLOCK OCCURRED POST IMPLANT OF A 23MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION BY RIGHT TRANSFEMORAL APPROACH. DURING IMPLANTATION, THE VALVE JUMPED IN LEFT VENTRICLE DIRECTION AND WAS IMPLANTED IN THE 50/50 (AORTIC: VENTRICULAR) POSITION. THE PATIENT HAD GOOD HEMODYNAMICS AND NO PARAVALVULAR LEAK. NO ACTION WAS NEEDED. THE POSITIONING PROBLEMS MAY HAVE OCCURRED DUE TO THE MASSIVE HYPERTROPHY OF LEFT VENTRICLE. AFTER THE IMPLANTATION, A THIRD-DEGREE HEART BLOCK OCCURRED, REQUIRING PACING WITH THE TEMPORARY PACEMAKER USED FOR IMPLANTATION. ADDITIONALLY, A PERMANENT PACEMAKER WAS REQUIRED ON THE SAME DAY AS THE PROCEDURE. THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Heart Block

  MAUDE report 25204215 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH THE JAPANESE TAVI REGISTRY REPORTING SYSTEM, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) AND RECEIVED A 26MM SAPIEN 3 ULTRA RESILIA VALVE. ON POSTOPERATIVE DAY 6, CEREBRAL INFARCTION (CI) WAS OBSERVED.

  Patient problems: Stroke/CVA

  MAUDE report 24926453 ↗
• InjuryMar 31, 2026Perivalvular Leak; Malposition of Device

  AS REPORTED BY OUR GERMAN AFFILIATE DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 20MM SAPIEN 3 ULTRA VALVE, ALTHOUGH THE VALVE WAS APPROPRIATELY POSITIONED BETWEEN THE BALLOON MARKERS PRIOR TO DEPLOYMENT, DURING VALVE DEPLOYMENT THE 20MM COMMANDER DELIVERY SYSTEM (DS) BALLOON INFLATED UNEXPECTEDLY, WITH THE PROXIMAL (OUTFLOW) PORTION INFLATING FIRST WHILE THE DISTAL (INFLOW) PORTION REMAINED SNARED WITH THE VALVE AND THEN ABRUPTLY INFLATING WITH THE PROXIMAL BALLOON PART, CAUSING AN UNPREDICTABLE VALVE DEPLOYMENT. CONSEQUENTLY, THE VALVE WAS IMPLANTED TOO HIGH IN THE AORTIC POSITION, WITH A HIGHER GRADE OF PARAVALVULAR LEAK OBSERVED ON FINAL FLUOROSCOPY. THE DELIVERY SYSTEM WAS SUBSEQUENTLY REMOVED WITHOUT ANY ISSUES, AND NO DAMAGE WAS OBSERVED ON THE 14FR ESHEATH+ UPON WITHDRAWAL. A SECOND VALVE WAS THEN IMPLANTED MORE VENTRICULAR WHICH RESULTED IN NO PARAVALVULAR LEAK. THE PROCEDURE WAS THEREFORE COMPLETED SUCCESSFULLY. NO INJURY WAS REPORTED, AND THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information

  MAUDE report 24744942 ↗
• 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 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE CLEARSIGHT MODULE IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 30 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 20 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON THE SAME SIDE AS THE ACUMEN CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206120 ↗
• MalfunctionJan 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE OF THE CLEARSIGHT MODULE IT WAS PROVIDING LOW SYSTOLIC AND MAP PRESSURE VALUES COMPARED TO THE ARTERIAL AND BRACHIAL MEASUREMENTS ON THE PATIENTS BEDSIDE GE MONITOR. THE VALUES RANGED ANYWHERE FROM 10 TO 70 POINTS DIFFERENT IN THE SYSTOLIC PRESSURE. FOR THE MAP THE DIFFERENCE COULD BE 10 UP TO 30 POINTS DIFFERENCE. THE PATIENT HAD A BRACHIAL OSCILLOMETRIC CUFF ON. IT WAS ON THE OPPOSITE ARM THEN IT WAS MOVED TO THE SAME SIDE AS THE ACUMEN CUFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206118 ↗
• 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 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(6) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567649 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(6) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567341 ↗
• MalfunctionNov 17, 2025High Readings; High Readings

  AS REPORTED, DURING USE OF THIS HEMOSPHERE CLEARSIGHT MODULE IN THREE DIFFERENT PROCEDURES (LARYNGECTOMY, GASTRECTOMY AND HEMICOLECTOMY), THE BLOOD PRESSURE VALUES DISPLAYED WERE 20 MMHG HIGHER THAN THOSE SHOWN ON THE ANESTHESIA MONITOR (MANUFACTURER COMPLAINT REFERENCES (B)(4) RESPECTIVELY). THE PRESSURE CONTROLLER, TRIFURCATED CABLE AND HEART REFERENCE SENSOR WERE TESTED WITHOUT SUCCESS. THERE WAS NO ERROR MESSAGE OR ALARM DISPLAYED. IT WAS DURING THE HEMICOLECTOMY CASE THAT THE ISSUE WAS RESOLVED REPLACING THE CLEARSIGHT MODULE, AFTER CONFIRMING THE ACCURACY OF THE ANESTHESIA MONITOR VALUES USING A BRACHIAL CUFF. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567198 ↗
• 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 ↗

Other Edwards Lifesciences LLC products

• Edwards SAPIEN 315 models · 6,905 reports · 1 recall
• EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
• Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
• INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
• EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
• SAPIEN 3 Ultra RESILIA4 models · 881 reports
• SAPIEN 3 Ultra System3 models · 876 reports
• FOGARTY32 models · 486 reports · 3 recalls