NX19 Oxygenator w/4-liter reservoir; right-side outlet port 3CX*NX19RERecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00699753450868), received between Oct 18, 2019 and Mar 30, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K180950); they may or may not involve this specific model.

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. Mar 1, 2023Open, Classified

   Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

   Z-1346-2023 · Root cause: Process control · FDA record ↗

2. Mar 1, 2023Open, Classified

   Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.

   Z-1347-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fluid/Blood Leak

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A BLOOD-TINGED DRAINAGE FROM GAS EXHAUST. THE PRODUCT WAS CHANGED OUT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 5 MINUTES DELAY. THERE WAS BLOOD LOSS BUT OF NO MEASURABLE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715970 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS PROCEDURE THE OXYGENATOR WAS FOAMING. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218274 ↗
• MalfunctionSep 13, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS PROCEDURE THE OXYGENATOR WAS FOAMING. *NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218008 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS SURGERY THERE WAS A BLOOD TO WATER LEAKAGE. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. PRODUCT WAS CHANGED OUT. THERE WAS ABOUT 4CC OF BLOOD LOSS. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669014 ↗
• MalfunctionMay 9, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAKAGE. NO HEALTH CONSEQUENCES OR IMPACT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281314 ↗
• MalfunctionJan 29, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE BLOOD WAS LEAKING BY WAY OF A BLOOD TO WATER LEAK IN THE DISPOSABLE OXYGENATOR HEAT EXCHANGER. AS PER THE USER FACILITY, AFTER INITIATION OF CARDIOPULMONARY BYPASS AND ARRESTING THE HEART TO BEGIN CABG (CORONARY ARTERY BYPASS GRAFT) PROCEDURE IT WAS NOTICED THAT A SMALL AMOUNT OF RED BLOOD CELLS HAD PENETRATED THE OXYGENATOR HEAT EXCHANGER AND WAS STAGNANT IN THE WATER HEATER/COOLER LINES. UPON CLOSE INSPECTION IT WAS CONFIRMED THAT BLOOD WAS LEAKING BY WAY OF A BLOOD TO WATER LEAK IN THE DISPOSABLE OXYGENATOR HEAT EXCHANGER. THE WATER LINES WERE REMOVED FROM THE DEVICE AND NOTED THAT A DROP OF BLOOD DID LEAK FROM THE OXYGENATOR HEAT EXCHANGER AT A RATE OF ONE DROP EVERY 3-5 MINUTES. THE PHYSICIANS WERE BOTH NOTIFIED AND DISCUSSED THE IMPLICATIONS OF NOT BEING ABLE TO HEAT THE BLOOD SINCE THIS MIGHT REVERSE THE LEAK AND CAUSE WATER TO ENTER THE PATIENT'S SYSTEMIC CIRCULATION MIXING WITH THEIR BLOOD AND CAUSING MASSIVE INFECTION AND HEMOLYSIS. THE ONLY OPTION IS TO STOP THE CPB (CARDIOPULMONARY BYPASS) AND REPLACE THE OXYGENATOR WITH A NEW ONE. THE DECISION WAS MADE TO DO AFTER THE CROSS CLAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602222 ↗
• MalfunctionNov 9, 2023Break; Break

  THE VENOUS TEMPERATURE PROBE BROKE OFF FROM THE OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102919 ↗
• MalfunctionJul 6, 2023Break; Break

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A FIBER BREAKAGE. AS PER THE SALES ASSOCIATE, AT THE VERY END OF A 223-MINUTE PUMP RUN THE OXYGENATOR APPEARED TO HAVE A PLASMA LEAK. THEY FINISHED THE CASE WITH NOTHING GOING WRONG AND THEY CAN TELL THERE WAS A PLASMA LEAK. ADDITIONALLY, AS PER THE CLINICAL SPECIALISTS, LOOKING AT THE COMPLAINT AND PHOTOS PROVIDED, IT APPEARED TO BE A FIBER BREAKAGE INSTEAD OF PLASMA LEAK. NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT . PRODUCT WAS NOT CHANGED OUT. THERE WAS A 3 ML BLOOD LOSS. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270458 ↗
• MalfunctionApr 8, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAKAGE; FOAM EXITING THE VENT. IT IS UNKNOWN WHETHER THE PRODUCT WAS CHANGED OUT, OR IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 14058454 ↗
• MalfunctionFeb 26, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED A PLASMA LEAK. AS PER USER FACILITY, THE O2 STARTED TO GO DOWN THEY RUN THEIR FIO2 AT 100% AND KEEP THEIR PO2 VALUES VERY HIGH. THE LOWEST PO2 VALUE ON CPB WAS 493 MMHG. THEY WERE ON CPB FOR 6.5 HOURS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388286 ↗
• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  NEW INFORMATION RECEIVED FROM THE PUMP RECORD/ CPB GRAPH SHOW THAT THE APPROXIMATE START OF LEAKAGE WAS ABOUT 5 HOURS AFTER THE START OF CARDIOPULMONARY BYPASS.

  Patient problems: Blood Loss; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065231 ↗
• MalfunctionNov 16, 2020Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION, AS PER THE CLINICAL SPECIALIST, PATIENT CO-MORBIDITIES COULD HAVE POTENTIALLY CONTRIBUTED TO THE CAUSE OF THE PLASMA LEAKAGE AS THE PATIENT'S COAGULATION SYSTEM MAY HAVE BEEN ALTERED DUE TO THEIR CO-MORBIDITIES, GENETIC FACTORS AND ENVIRONMENTAL FACTORS.

  Patient problems: Blood Loss

  MAUDE report 10848834 ↗
• MalfunctionJul 10, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THEY DISCOVERED A LOOSE THERMISTOR AT THE VENOUS INLET OF THE RESERVOIR FROM THE OXYGENATOR DURING PREPARATION. THEY WERE ABLE TO EXCHANGE THE OXYGENATOR AND RESERVOIR. NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10259678 ↗
• MalfunctionMay 18, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER 3 HOURS ON CARDIOPULMONARY BYPASS, DURING AORTIC VALVE SURGERY, THERE WAS AROUND 100ML PLASMA LEAKAGE. PER USER FACILITY, THE PATIENT WAS FOR RE-OPERATION AKE & HF ABLATION. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER 4.5 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10067578 ↗
• MalfunctionApr 2, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS PLASMA LEAKAGE AT GAS INLET AND GAS OUTLET SIDE. PER USER FACILITY, THE REPORT DOCUMENTS THE EVENT AND ONLINE DATA FOR A LONGER CASE WITH TWO SESSIONS; FIRST FOR APPROX. 6.5H (INCLUDING PERFUSION/REPERFUSION, ETC) AND SECOND FOR APPROX. 1.75H. IN THE SECOND SESSION, A PLASMA LEAKAGE WAS DISCOVERED AND A SECOND OXYGENATOR WAS ADDED AFTER APPROX. 0,25H PERFUSION TIME. THE FIRST SESSION STOPPED @16:40 LOCAL TIME. THE SECOND SESSION STARTED @ 19:04 LOCAL TIME AND STOPPED @ 20:47 LOCAL TIME; PLASMA LEAKAGE OBSERVED AND 2ND OXY ADDED. THERE IS NO ACT/HEPARIN INFO DOCUMENTED SINCE THE LAST ACT VALUE (@16:11). THE PLASMA LEAKAGE WAS OBSERVED DURING THE SECOND SESSION THEREFORE IT APPEARS THAT THE OXY WAS ALREADY IN USE (FIRST SESSION + STANDBY) FOR APPROX. 9H BEFORE THE SECOND SESSION STARTED. THERE WAS AROUND 1 MINUTE DELAY. THERE WAS LESS THAN 100ML BLOOD LOSS + PLASMA LEAKAGE ABOUT 200ML. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; Injury

  MAUDE report 9918042 ↗
• MalfunctionApr 2, 2020Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION RECEIVED THAT, AFTER CHANGING WITH THE OXYGENATOR, WITH THE FLOW DIAGRAM OF FIO2 AND GAS FLOW, SHOWS 10L/MIN AND WITH 100% FIO IN THE BLOOD GIVES A CO2 OF 47MMHG AND PO2 OF 111MMHG. THEY PERCEIVED THIS AS INSUFFICIENT OXYGENATION WITH THESE GAS SETTINGS.

  Patient problems: Blood Loss

  MAUDE report 9918015 ↗
• InjuryApr 1, 2020Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS NOT ENOUGH OXYGENATION AFTER 1 HOUR AND 21 MINUTES ON BYPASS. AS PER THE USER FACILITY, AN INITIAL DOSE OF 10.000 IU OF HEPARIN WAS DOCUMENTED FOR THE PRIMING ONLY. THEN AN INITIAL ACT OF 999 SEC WAS DOCUMENTED AFTER 15 MINUTES ON BYPASS. THE REPORT DOCUMENTS USAGE OF HEMOFILTRATION, CLOSE TO THE ENTIRE DOCUMENTED PERFUSION TIME, WITH A HIGH TOTAL AMOUNT OF HEMOFILTRATION OF (12.000 ML). FURTHERMORE THE PROVIDED CASE REPORT DOCUMENTS LOWER LEVEL OF HGB AND HCT DURING THE CASE. THERE WAS A 1 MINUTE DELAY FOR THEY CHANGED OUT THE HLM (HEART LUNG MACHINE) WITH THE NEW OXYGENATOR. THERE WAS A BLOOD LOSS OF 100 ML. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss; Injury

  MAUDE report 9911326 ↗
• InjuryFeb 18, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS FOAMING. PER USER FACILITY, THE CASE WAS AN AORTIC ANEURYSM DISSECTION AND THEY WERE ON BYPASS FOR 3.5 HOURS THEN ANOTHER 1 TO 1.5 HOURS OFF AGAIN AND THEN ON FOR 15-20 MINUTES. THE OXYGENATOR WAS FOAMING AND THE END OF THE CASE, P02 DROPPED, THEY TRANSFERRED TO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), WHICH WAS NECESSARY DUE TO THE PATIENT'S RIGHT HEART FAILURE. THE PATIENT EXPIRED AT A LATER DATE. THERE WAS SLIGHT BLOOD COLORED PLASMA AT THE END. THE PRODUCT WAS NOT CHANGED OUT BUT THEY DID ADD A FX15 OXYGENATOR INTO THE CIRCUIT TO HAVE AS A BACKUP, (IT WAS NOT USED). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Death; Heart Failure

  MAUDE report 9721858 ↗
• MalfunctionFeb 14, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, A FLUID FOAMING WAS NOTED AT THE END OF CPB. DIAGNOSIS WAS A TYPE A DISSECTION. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9713703 ↗
• MalfunctionFeb 7, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS LEAKED WITH BUBBLING FLUID. .NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. .PRODUCT WAS NOT CHANGED OUT. .PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9680878 ↗
• MalfunctionJan 24, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS PLASMA LEAKAGE AFTER 5 HOURS ON SURGERY: TYPE A DISSECTION. THE LEAKAGE OCCURRED AT THE END OF THE PROCEDURE WITH ABOUT 100-150ML PLASMA ON THE FLOOR. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9629826 ↗
• MalfunctionJan 17, 2020Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR DID NOT OXYGENATE. THERE WAS A GREAT DEAL OF FAT IN THE RESERVOIR & OXYGENATOR. THE INITIAL HEPARIN DOSE WAS 48K, AND BEFORE GOING BACK ON BYPASS ANOTHER 48K WAS GIVEN. ADDITIONALLY, ANOTHER 10K OF HEPARIN WAS ADDED IN THE PUMP PRIOR TO GOING ON. TO START, IT WAS A 1:1 RATIO OF GAS TO BLOOD FLOW. THE SWEEP WAS UNABLE TO BE DECREASED DURING THE FIRST HALF OF THE PROCEDURE. THE PATIENT WAS WEANED OFF BYPASS AND IT WAS DETERMINED THAT THE PATIENT COULD NOT SUPPORT METABOLIC NEEDS ON THEIR OWN SO BYPASS WAS INITIATED AGAIN. THE DEVICE AND CIRCUIT WERE NOT CIRCULATED BETWEEN BYPASS RUNS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9603807 ↗
• MalfunctionJan 8, 2020Leak/Splash; Leak/Splash

  NEW INFORMATION WAS RECEIVED INDICATING THAT THE ISSUE OCCURRED ABOUT 4 HOURS INTO BYPASS. THE DEVICE HAD 2 AIR BUBBLE DETECTORS ON IT. AS A RESULT OF THE FOAMING, THE PERFUSIONIST USED ONE AIR BUBBLE DETECTOR UNDER THE RESERVOIR OUTLET AND MOVED ONE TO THE OXYGENATOR OUTLET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9566283 ↗
• MalfunctionJan 3, 2020Leak/Splash; Leak/Splash

  NEW INFORMATION RECEIVED THAT THERE WAS NO DELAY IN THE PROCEDURE, NO BLOOD LOSS, AND THE SURGERY WAS COMPLETED WITH NO PATIENT EFFECT. THE USER FACILITY STATED THAT THIS WAS AN EMERGENCY CASE. THE PATIENT CAME IN WITH IMPELLA SYSTEM AND LEFT THE OPERATING ROOM WITH IMPELLA AND ECMO.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9544985 ↗
• MalfunctionDec 13, 2019Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS IN FOR AORTIC VALVE REPLACEMENT (AVR), SEPTAL MYECTOMY AND MAZE PROCEDURE. THE PATIENT WAS COOLED TO 28 DEGREE CELSIOUS DURING FIRST PUMP RUN AND CO2 FLUSH IN PERICARDIUM FOR OPEN PROCEDURES. THEY WERE ON AND OFF CPB THREE TIMES WITH APPROXIMATELY 280 MINUTES OF TOTAL PUMP RUN. PER USER FACILITY THE THIRD TIME BACK ON CPB WAS FOR BLEEDING CONTROL DUE TO PROLENE DEFICIENCY. THE ISSUE WAS NOTED AFTER 3RD PUMP RUN.

  Patient problems: No Patient Involvement

  MAUDE report 9467262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180950. One submission often covers many models, so check the product and lot details in each record.

• Z-2104-2019 · Jun 14, 2019 · Terminated
  Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
• Z-2103-2019 · Jun 14, 2019 · Terminated
  Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
• Z-2101-2019 · Jun 14, 2019 · Terminated
  Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
• Z-2102-2019 · Jun 14, 2019 · Terminated
  Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW