Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. 3CX*FX15RE40CRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00699753450813), received between Sep 5, 2018 and Nov 1, 2024 — classified as 4 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (11 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED CLOTTING IN THE VENOUS SOCK, ABOUT THE SIZE OF A QUARTER. *NO HEALTH CONSEQUENCE OR IMPACT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585576 ↗
• MalfunctionOct 4, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED CLOTTING IN THE VENOUS SOCK. *NO HEALTH CONSEQUENSES OR IMPACT *PRODUCT WAS NOT CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20374373 ↗
• MalfunctionJul 18, 2024Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED A HIGH PRESSURE EXCURSION. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776356 ↗
• MalfunctionMay 24, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR LEAKED. THE UNIT WAS NOT CHANGED OUT, AND AS A MITIGATION, THEY OPENED THE RECIRC LINE TO OXYGENATE MORE. *NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT *THERE WAS 5 MILLILITER (ML) OF BLOOD LOSS *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391911 ↗
• MalfunctionApr 17, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION FORM THE CLINICAL SPECIALIST INDICATES THAT THE COMPLAINT INVOLVED AN OXYGENATOR THAT APPARENTLY EXPERIENCED A HIGH PRESSURE EXCURSION EVENT (HPE) DURING CARDIOPULMONARY BYPASS, WITH INCREASING (REVOLUTIONS PER MINUTE) RPMS AND DECREASING BLOOD FLOW RATES. A TERUMO ICP DISPOSABLE CENTRIFUGAL PUMPHEAD WAS USED ON A TERUMO SYSTEM 1 HEART LUNG MACHINE WITH CENTRIFUGAL PUMP MOTOR. THE OXYGENATOR AND DISPOSABLE CENTRIFUGAL PUMPHEADS WERE NOT CHANGED OUT. THE CENTRIFUGAL DRIVE MOTOR WAS CHANGED OUT WITH ANOTHER DRIVE MOTOR, WITH NO IMPROVEMENT IN FLOWS. AS THE CLINICIAN STARTED TO REWARM, THE BLOOD FLOW RATES IMPROVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE PUMP RECORD AND BLOOD GASES WERE SHARED. THIS CASE WAS A MITRAL VALVE REPAIR WITH THE PATIENT CANNULATED IN THE FEMORAL AORTA. BYPASS WAS INITIATED AT 8:02AM. THE FIRST RPMS AND ARTERIAL BLOOD FLOWS RECORDED WERE 2537RPM AND 3.68LPM AT 8:03AM. THE ARTERIAL BLOOD TEMPERATURE WAS 32 DEGREES CELSIUS AT THIS TIME. BY 8:06AM, THE RPMS HAD INCREASED TO 3500-3600RPM AND THE ARTERIAL BLOOD FLOW RATES HAD DECREASED TO 2.12-2.32 LPM BY 8:15AM. THE ARTERIAL BLOOD TEMPERATURES FROM 8:08AM TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126692 ↗
• MalfunctionDec 21, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE UNIT BOX HAS A TORN LABEL. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378542 ↗
• MalfunctionAug 11, 2023Partial Blockage; Partial Blockage

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THERE WAS A PURGE LIQUID OUTLET BLOCKAGE IN THE SAMPLING LINE. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17513433 ↗
• MalfunctionJul 3, 2023Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD AN OVER PRESSURIZATION. THE PROCEDURE WAS AN NRP PROCEDURE, THE PATIENT IS PRONOUNCED DEAD BEFORE THE PERFUSIONIST GOES ON BYPASS; THE PATIENT DIED OF CEREBRAL STROKE. THE PATIENT HAD AN ONGOING BYPASS TO OXYGENATE AND PRESERVE THE KIDNEYS FOR ORGAN HARVEST. THE PERFUSIONIST WENT ON BYPASS AND IMMEDIATELY HAD DECREASING LINE PRESSURE AND FLOWS BUT INCREASING RPMS CONSTANTLY. THIS CONTINUED UNTIL HE WAS UNABLE TO FLOW AT ALL AFTER 34 MINUTES AND HAD TO COME OFF BYPASS AND TERMINATE THE PROCEDURE. THERE WAS NOT ENOUGH FORWARD FLOW TO EVEN CIRCULATE THROUGH THE RECIRC LINE AFTER HE WAS OFF BYPASS AND HAD SUCKED THE CIRCUIT (AND OXY) DRY (OF BLOOD) AND REPLACED WITH 2 LITERS CRYSTALLOID TO TRY AND CIRCULATE. THERE WAS NO CLOT OR FIBRIN STRANDS SEEN ANYWHERE IN FX15 (EVEN AT THE SURGICAL FIELD). PATIENT WAS NORMOTHERMIC. FEMORAL CANNULATION 19F RETURN ARTERY AND 25F VEIN CANNULAS. AT 22:55, ANESTHESIA GAVE 30, 000 HEPARIN BEFORE EXTUBATING. 10,000 HEPARIN IN PERFUSION PRIME AS WELL AS 2L NORMOSOL, 10MG DECURONIUM, 100MEQ NAHCO3, 2G MAGNESIUM SULFATE, 1G 10% CALCIUM, 400MG CIPROFLOX

  Patient problems: No Clinical Signs, Symptoms or Conditions; Renal Failure

  MAUDE report 17248741 ↗
• MalfunctionJun 20, 2023Use of Device Problem; Use of Device Problem

  THE OXYGENATOR HAS LOST ITS OXYGENATING CAPACITY.

  Patient problems: Hypoventilation

  MAUDE report 17162055 ↗
• MalfunctionJun 16, 2023Low Readings; Low Readings

  PER THE CLINICAL SPECIALIST, THE CUSTOMER SHARED SOME PARTS OF THE PUMP RECORD. THE PATIENT WAS PLACED ON CPB AT 10:06AM WITH NO ISSUES AND AN ISTAT BLOOD GAS REVEALED A PO2 OF 506MMHG AT FIO2 OF 100% AT THAT TIME. THIS WAS USED TO CALIBRATE THE CDI 550 SYSTEM TO PROVIDE THE FOLLOWING PO2S. THE PO2S DECREASED MARGINALLY IN THE 400S MMHG RANGE OVER THE NEXT FEW HOURS OF BYPASS. AT 1:45PM, THE PO2 WAS 442 MMHG. THE ACT AT THAT TIME WAS 581 SECONDS. HEPARIN IN THE AMOUNT OF 10,000 IU WAS GIVEN AT THAT TIME. THEN AT 1:57PM, AN UNKNOWN AMOUNT OF CRYOPRECIPITATE WAS GIVEN. THE PO2S STEADILY DROPPED FROM THIS POINT FORWARD, FROM 297MMHG AT 2:05PM DOWN TO 140MMHG AT 2:43PM. THE VENOUS SATURATION DROPPED FROM 76% TO 72% AT THOSE TIMES. THE ACT AT 2:23PM WAS 841 SECONDS AND AT 2:43PM WAS 741 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145822 ↗
• MalfunctionApr 21, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  BOXES BEEN DAMAGED BY DEFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789372 ↗
• InjuryMar 14, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST INDICATED THAT THERE WAS A SLIGHT DELAY IN THE PROCEDURE AND THERE WAS 260 ML OF BLOOD LOSS IN THE PROCEDURE WITH NO HARM TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16536957 ↗
• MalfunctionMay 9, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR GROUP THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ADEQUATE MEMBRANE OXYGENATION WITH PARAMETERS THAT EVIDENCE TO A LOW PO2 IN EXTRACORPOREAL CIRCULATION WITH A FLOW RATE BETWEEN LIMIT. MANY CHANGES IN FIO2, AND ARTERIAL FLOW TO SUPPORT THE LOW OXYGENATION. THE LOCATION OF THE HOSPITAL HAS AN ATMOSPHERIC PRESSURE OF 560 MMHG AND AN ALTITUDE OF 2640 METERS OVER SEA LEVEL. THE PERFUSIONIST BELIEVES THAT THE LOW OXYGEN DELIVERY IS DUE TO THE ATMOSPHERIC PRESSURE AND HIGH LEVEL CITY. NO CONSEQUENCE OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338694 ↗
• MalfunctionMay 9, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR GROUP THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ADEQUATE MEMBRANE OXYGENATION WITH PARAMETERS THAT EVIDENCE TO A LOW PO2 IN EXTRACORPOREAL CIRCULATION WITH A FLOW RATE BETWEEN LIMIT. MANY CHANGES IN FIO2, AND ARTERIAL FLOW TO SUPPORT THE LOW OXYGENATION. THE LOCATION OF THE HOSPITAL HAS AN ATMOSPHERIC PRESSURE OF 560 MMHG AND AN ALTITUDE OF 2640 METERS OVER SEA LEVEL. THE PERFUSIONIST BELIEVES THAT THE TO LOW OXYGEN DELIVERY IS DUE TO THE ATMOSPHERIC PRESSURE AND HIGH LEVEL CITY. NO CONSEQUENCE OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338666 ↗
• MalfunctionMay 9, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR GROUP THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ADEQUATE MEMBRANE OXYGENATION WITH PARAMETERS THAT EVIDENCE TO A LOW PO2 IN EXTRACORPOREAL CIRCULATION WITH A FLOW RATE BETWEEN LIMIT. MANY CHANGES IN FIO2, AND ARTERIAL FLOW TO SUPPORT THE LOW OXYGENATION. THE LOCATION OF THE HOSPITAL HAS AN ATMOSPHERIC PRESSURE OF 560 MMHG AND AN ALTITUDE OF 2640 METERS OVER SEA LEVEL. THE PERFUSIONIST BELIEVES THAT THE LOW OXYGEN DELIVERY IS DUE TO THE ATMOSPHERIC PRESSURE AND HIGH LEVEL CITY. NO CONSEQUENCE OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338492 ↗
• MalfunctionMay 9, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR GROUP THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ADEQUATE MEMBRANE OXYGENATION WITH PARAMETERS THAT EVIDENCE TO A LOW PO2 IN EXTRACORPOREAL CIRCULATION WITH A FLOW RATE BETWEEN LIMIT. MANY CHANGES IN FIO2, AND ARTERIAL FLOW TO SUPPORT THE LOW OXYGENATION. THE LOCATION OF THE HOSPITAL HAS AN ATMOSPHERIC PRESSURE OF 560 MMHG AND AN ALTITUDE OF 2640 METERS OVER SEA LEVEL. THE PERFUSIONIST BELIEVES THAT THE LOW OXYGEN DELIVERY IS DUE TO THE ATMOSPHERIC PRESSURE AND HIGH LEVEL CITY. NO CONSEQUENCE OR IMPACT TO THE PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338453 ↗
• MalfunctionMar 10, 2022Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE CO2 WAS HIGH AND DIFFICULT TO CONTROL. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT . PRODUCT WAS NOT CHANGED OUT . PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721710 ↗
• InjuryJan 15, 2022Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS AN INCREASE IN THE INLET PRESSURES OF THE OXYGENATING CHAMBER THAT IS NOTED WITH A DECREASE IN GAS EXCHANGE. AS PER THE SUBSIDIARY, THE PATIENT WAS WITH ISCHEMIC HEART DISEASE UNDERGOING CORONARY ARTERY BYPASS SURGERY WITH URGENCY. AFTER 30 MINUTES FROM THE AORTIC CLAMPING WITH AN ACT GREATER THAN 480, AN INCREASE IN THE INLET PRESSURES OF THE OXYGENATING CHAMBER WAS NOTED WITH A DECREASE IN GAS EXCHANGE; AFTER 6 MINUTES THE INLET PRESSURE REACHES VALUES EXCEEDING 600 MMHG AT THE INLET AND BRINGING VENTILATION AT 100% OXYGEN WITH 9.5 LITERS /M OF AIR AT A BLOOD FLOW OF 5 LITERS /MINUTES. THERE WAS A PO2 OF 69 MMHG AND PCO2 WITHIN THE NORM BUT VISUALLY ONE BEGAN TO NOTICED FIBRIN FILINGS ADHERED AROUND THE POLYCARBONATE OF THE OXYGENATING CHAMBER ESPECIALLY TOWARDS THE PART OF THE CONNECTIONS FOR THE THERMOCIRCULATOR. AT THIS POINT THE USER DECIDES TO BRING THE BLOOD TEMPERATURE TO 28 °C, THE INLET PRESSURES OF THE OXYGENATING CHAMBER REACH VALUES OF AROUND 800 MMHG, THEREFORE IT IS DECIDED TO PROCEED WITH THE IMMEDIATE REPLACEMENT OF THE DEVICE BY INSTALLING A NEW OXYGENATOR OF THE SAM

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13262466 ↗
• MalfunctionSep 2, 2021Material Deformation; Material Deformation

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE PRODUCT HAS IRREGULAR SHAPE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414508 ↗
• MalfunctionJul 15, 2021Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING OUT OF BOX, THE CUSTOMER OPENS THE WRONG OXYGENATOR PACK. INSTEAD OF RECEIVING A FX25 THE CUSTOMER RECEIVED A FX15RE40. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177461 ↗
• MalfunctionNov 25, 2020Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY NOTICED THE TEMPERATURE PROBE PORT WAS BROKEN. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10906186 ↗
• MalfunctionJul 28, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE OXYGENATOR HAD A YELLOWISH LINE RUNNING THROUGH THE FIBER BUNDLE. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10331620 ↗
• MalfunctionJun 23, 2020Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PROGRESSIVE INCREASE IN THE PRE OXYGENATION PRESSURE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10184200 ↗
• MalfunctionJun 1, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE SAMPLING MANIFOLD STOPCOCK FURTHEST TO THE LEFT SEEMED TO BE SUCKING IN AIR THROUGH A CRACK. AS PER THE USER FACILITY, WHENEVER THE PUMP WAS STOPPED, THE SAMPLING MANIFOLD STOPCOCK FURTHEST TO THE LEFT SEEMED TO BE SUCKING IN AIR THROUGH A CRACK THAT WAS NOT VISIBLE TO THEM AT THE TIME. THE AIR WOULD ENTER THE MANIFOLD, MOVED UP THE MANIFOLD LINE, AND ENTER THE VENOUS LINE WHERE IT ATTACHES. THIS HAPPENED REGARDLESS OF THE ORIENTATION OF THE STOPCOCK. THEY CHANGED THE TUBING AND IT STILL OCCURRED WHICH TOLD THEM IT WAS THE ACTUAL MANIFOLD ITSELF. ADDITIONALLY, IF INSPECTED VERY CLOSELY, IT SEEMS THERE WAS A HOLE AT THE BASE OF THE STOPCOCK." NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10105752 ↗
• MalfunctionApr 10, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, THEY NOTICED THAT THE SAMPLE LINE ATTACHED TO MANIFOLD ON OXYGENATOR WOULD NOT ALLOW FLOW WHILE PRIMING CIRCUIT. AS PER THE USER FACILITY, THEY VISUALLY CHECKED OF ONE WAY VALVE AND IT WAS IN BACKWARDS. THEY OPENED ANOTHER OXYGENATOR AND USED LINE FROM THAT UNIT. LINE WAS CHANGED OUT USING LINE FROM ANOTHER FX15 ON THE SHELF. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9949459 ↗