NX19 Oxygenator w/4-liter reservoir; left-side outlet port 3CX*NX19RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00699753450875), received between Apr 25, 2019 and Jul 11, 2025 — classified as 3 deaths, 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (20 reports).

5 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A FOAMING OUT THE EXHAUST PORT AND FAILED TO TRANSFER OXYGEN. NO CONSEQUENCE OR HEALTH IMPACT TO PATIENT. THERE WAS A DELAY OF 5 MINUTES. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485137 ↗
• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718944 ↗
• MalfunctionMar 14, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THEY NOTICED PLASMA LEAK 274 MINUTES INTO BYPASS. *NO HEALTH CONSEQUENCES OR IMPACT. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21608390 ↗
• MalfunctionNov 1, 2024Use of Device Problem; Use of Device Problem

  TERUMO CARDIOVASCULAR HAS BEEN INFORMED THROUGH PROACTIVE CUSTOMER SURVEYS FOR POST MARKET SURVEILLANCE ACTIVITIES, THAT THE USER FACILITY EXPERIENCED A FAILURE WITH THE OXYGENATOR. AS THIS INFORMATION WAS RECEIVED THROUGH A CUSTOMER SURVEY, IT IS UNKNOWN WHEN THE EVENT OCCURRED, IF THERE WAS A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF THERE WAS ANY PATIENT EFFECT AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20592068 ↗
• InjuryNov 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  TERUMO CARDIOVASCULAR HAS BEEN INFORMED THROUGH PROACTIVE CUSTOMER SURVEYS FOR POST MARKET SURVEILLANCE ACTIVITIES, THAT THE USER FACILITY EXPERIENCED A MALFUNCTION OF THE DEVICE THAT RESULTED IN >100ML OF BLOOD LOSS. AS THIS INFORMATION WAS RECEIVED THROUGH A CUSTOMER SURVEY, IT IS UNKNOWN WHEN THE EVENT OCCURRED, IF THERE WAS A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF THERE WAS ANY PATIENT EFFECT AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20591779 ↗
• InjuryNov 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  TERUMO CARDIOVASCULAR HAS BEEN INFORMED THROUGH PROACTIVE CUSTOMER SURVEYS FOR POST MARKET SURVEILLANCE ACTIVITIES, THAT THE USER FACILITY EXPERIENCED A MALFUNCTION OF THE DEVICE THAT RESULTED IN >100ML OF BLOOD LOSS. AS THIS INFORMATION WAS RECEIVED THROUGH A CUSTOMER SURVEY, IT IS UNKNOWN WHEN THE EVENT OCCURRED, IF THERE WAS A DELAY IN THE PROCEDURE, IF THE PRODUCT WAS CHANGED OUT, IF THE SURGERY WAS COMPLETED SUCCESSFULLY, OR IF THERE WAS ANY PATIENT EFFECT AS A RESULT OF THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20591754 ↗
• MalfunctionSep 20, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL SPECIALIST STATES THAT, A PARTIAL PUMP RECORD WAS SHARED, AND THIS CASE WAS A REPAIR OF AN AORTIC ANEURYSM. THERE WAS A 2-MINUTE DELAY OF OXYGENATION TO THE PATIENT. THE PARTIAL PRESSURE OF OXYGEN (PO2) OXYGENATION VALUE HAD DROPPED TO A CRITICAL VALUE OF 85MMHG RIGHT BEFORE THE OXYGENATOR CHANGEOUT. THE ACTIVATED CLOTTING TIME (ACT) AT THAT TIME WAS 653 SECONDS PER THE CLINICIAN, WHICH IS ADEQUATE. AFTER THE NEW OXYGENATOR WAS INLINE AND BYPASS WAS RESUMED, THE PO2 OXYGENATION VALUE WAS AN ACCEPTABLE 421MMHG. THE COMPLAINT OXYGENATOR WAS FUNCTIONING AT THE BEGINNING OF BYPASS, WITH FIRST PO2 VALUE OF 228MMHG WITH AN UNKNOWN FRACTION INSPIRED OXYGEN (FIO2) SETTING. THE PO2 VALUE GRADUALLY DROPPED UNTIL A CRITICAL VALUE OF 73MMHG WAS REACHED. ONCE THE PO2 VALUE REMAINED BELOW ACCEPTABLE LEVELS AT 85MMHG, THE DECISION TO CHANGE OUT THE OXYGENATOR WAS MADE.

  Patient problems: Insufficient Information

  MAUDE report 20269450 ↗
• MalfunctionJun 15, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS AN OXYGENATOR FOAMING AT THE 10 HOUR MARK. AS PER THE SUBSIDIARY, THE PERFUSIONIST WAS ON PUMP FOR 12 HOURS AND NOTICED OXY WAS FOAMING AT THE 10 HOUR MARK. NO REDUCTION IN PERFORMANCE NOTED. CONTINUED ON AND FINISHED CASE WITH NO PATIENT ISSUES. *NO KNOWN CONSEQUENCE OR HEALTH IMPACT TO PATIENT *PRODUCT WAS NOT CHANGED OUT *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544119 ↗
• MalfunctionMay 3, 2024Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAS COMPLETELY STOPPED THE OXYGENATION. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT AND IF THERE WAS A BLOOD LOSS AS RESULT OF THE REPORTED ISSUE. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 19242866 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Leak/Splash

  THE USER "FACILITY" REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER "CARDIOPULMONARY" "BYPASS", THE OXYGENATOR WAS FOUND WITH PLASMA LEAK. AS PER THE USER FACILITY, THIS WAS DISCOVERED AFTER BYPASS WAS DISCONTINUED; THEREFORE, THE PRODUCT WAS NOT CHANGED OUT, THE CASE WAS FINISHED SUCCESSFULLY WITH VERY LITTLE BLOOD LOSS, AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18752083 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION FROM THE CLINICAL SPECIALIST STATES THAT, THE OXYGENATOR IN THIS COMPLAINT WAS NOT CHANGED OUT AS THE PATIENT WAS 20 TO 30 MINUTES FROM WEANING FROM BYPASS. THE PCO2 VALUES DID RISE IN BLOOD GAS RESULTS AND THE CLINICIAN HAD TO ADJUST THE SWEEP RATE FROM 2LPM TO 4LPM TO COMPENSATE FOR THE DECREASED CO2 REMOVAL PERFORMANCE AS A RESULT OF THE PLASMA LEAK. THE OXYGEN TRANSFER PERFORMANCE WAS DEEMED CLINICALLY ACCEPTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694080 ↗
• MalfunctionFeb 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT AFTER CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAKED. AS PER THE USER FACILITY, THE REPORTED ISSUE DID NOT CAUSE ANY DELAY, THE UNIT WAS NOT CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689979 ↗
• MalfunctionFeb 2, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS FOAMY. AS PER THE USER FACILITY, THE UNIT WAS NOTED TO BE FROTHY WHEN CLEANING UP APPROXIMATELY 1 HOUR AFTER BYPASS. THE OXYGENATOR HAS BEEN PRIMED FOR 9 HOURS AT THIS POINT IN TIME. THERE WAS NO ABNORMALITY DURING BYPASS, AND NO NEGATIVE EFFECT ON PATIENT AND ISSUES THAT WOULD CONTRIBUTE TO THE EVENT. THEY WERE 288 MINUTES ON PUMP, 2 PUMP RUNS, AND 2 CROSS CLAMPS. NO PROTAMINE GIVEN BETWEEN PUMP RUNS. SWEEP FIO2 WAS KEPT 80-100% DURING THE PROCEDURE, 1-5-2.5 L/MIN. CLEVIDIPINE WAS USED ON BYPASS FOR AN HOUR. NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634725 ↗
• MalfunctionJan 22, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, PLASMA LEAKAGE WAS OBSERVED. AS PER THE USER FACILITY, THE PROCEDURE WAS FOR A REDO OF AORTIC ROOT REPLACEMENT + EMERGENT CABG (CORONARY ARTERY BYPASS GRAFT). THE PATIENT WAS GIVEN PROTAMINE AFTER 14:34 BYPASS RUN. THE PT DECOMPENSATED WITH MAPS (MEAN ARTERIAL PRESSURE) REACHING AS LOW AS 25 WHILE RE-CANNULATING BEFORE GOING BACK ON CPB (CARDIOPULMONARY BYPASS) AT 1500. THE PLASMA LEAK FIRST NOTICED AT 1520. THERE WAS NO BLOOD LOSS DUE TO LEAK; HOWEVER, THE PATIENT DID RECEIVE BLOOD PRODUCTS SECONDARY TO OUTSIDE FACTORS OF THE PLASMA LEAK. THE BLOOD WAS SUCKED OUT OF THE NX 19 OXYGENATOR. THE PRODUCT WAS NOT CHANGED OUT; THEY DID NEED TO SPLICE FX 15 OXYGENATOR TO THE RECIRC LINE TO ADEQUATELY CONTROL THE PATIENTS PCO2 (PARTIAL PRESSURE OF CARBON DIOXIDE). *THE DELAY WAS UNDETERMINED *PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18560070 ↗
• InjuryAug 11, 2023Use of Device Problem; Use of Device Problem

  NEW INFORMATION FROM THE CLINICAL SPECIALIST BASED ON HIS PHONE INTERVIEW HELD WITH THE DIRECTION OF PERFUSION INDICATES THAT, THE PATIENT WITH A HEIGHT OF 179CM AND WITH A BSA OF 2.34M2. THE TOTAL PUMP RUN TIME WAS 795 MINUTES, WITH A CHANGE OF OXYGENATOR OCCURRING AT APPROXIMATELY THE 8 HOUR MARK OF BYPASS. THIS FAILURE WAS AN ACUTE CHANGE IN GAS TRANSFER PERFORMANCE, WITH PCO2 RISING AND PO2 FALLING INTO THE LOW 100S. THE CASE WAS A CABG THAT ALSO NEEDED A HEMI-ARCH AORTA REPLACEMENT. THE PATIENT DID HAVE HYPERLIPIDEMIA PRE-OPERATIVELY, AND THIS MAY HAVE CONTRIBUTED TO THE PLASMS LEAK. NO HEPCON DEVICE WAS USED TO MEASURE THE BLOOD HEPARIN CONCENTRATION. PER THE PERFUSION DIRECTOR, THE ACTS WERE WELL ABOVE 1000 SECONDS, WITH THE LOWEST ACT OF VALUE OF 483 SECONDS. THE PATIENT WAS ULTRA FILTRATED DURING THE CASE, 2500ML OF FLUID REMOVED WITH AN EVENTUAL REMOVAL OF 3500ML AT THE END OF THE CASE. THE CONTRIBUTING FACTORS APPEAR TO BE THE ACUITY OF THE PATIENT, THE SURGICAL INVASIVENESS OF THE PROCEDURE BEING PERFORMED, THE CO-MORBIDITIES THE PATIENT COMES TO SURGERY WITH, BASELINE CHEMISTRY VALUES OF THE VARIOUS LIPID MARKERS, AND ACID BASE STATUS UPON ARRIVAL IN THE OPERATING SUIT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17512436 ↗
• InjuryAug 11, 2023Use of Device Problem; Use of Device Problem

  NEW INFORMATION FROM THE CLINICAL SPECIALIST BASED ON HIS PHONE INTERVIEW HELD WITH THE DIRECTION OF PERFUSION INDICATES THAT, THE PATIENT WITH THE HEIGHT OF 186CM AND BSA OF 2.4M2. THE PATIENT WAS ON VA ECMO AND IMPELLA FOR HEART FAILURE AND PRESENTED TO THE OR FOR A HEART TRANSPLANT. THE PATIENT POST -OPERATIVELY HAD A REJECTION OF THE TRANSPLANTED HEART AND SUBSEQUENTLY UNDERWENT A SECOND HEART TRANSPLANT, DURING WHICH THE FAILURE OF THE NX19 OXYGENATOR OCCURRED. THE ENTIRE PUMP RUN FOR THIS NX19OXYGENATOR WAS 437 MINUTES. THE PATIENT WAS WEANED OFF BYPASS THREE TIMES, FOR 10 MINUTES AT A TIME, DURING WHICH NO PROTAMINE REVERSAL WAS GIVEN AND RECIRCULATION OF THE BLOOD WAS MAINTAINED THROUGH THE RECIRCULATION LINE OF THE PERFUSION CIRCUITRY. NO HEPCON DEVICE WAS USED TO MEASURE BLOOD CONCENTRATIONS OF HEPARIN, ALTHOUGH PER THE DIRECTOR, THE ACT VALUES WERE ADEQUATE DURING THE RUN. THE CONTRIBUTING FACTORS APPEAR TO BE THE ACUITY OF THE PATIENT, THE SURGICAL INVASIVENESS OF THE PROCEDURE BEING PERFORMED, THE CO-MORBIDITIES THE PATIENT COMES TO SURGERY WITH, BASELINE CHEMISTRY VALUES OF THE VARIOUS LIPID MARKERS, AND ACID BASE STATUS UPON ARRIVAL IN THE OPERATING SUITE (AN INDICAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17512406 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT, THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS, THERE WAS NO DELAY IN THE PROCEDURE, THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 5-10 CC OF BLOOD LOSS. IN ORDER TO MITIGATE OR RESOLVE THE PROBLEM, THEY MOPPED UP THE FOAM IN THE FLOOR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424556 ↗
• DeathAug 27, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAKAGE. THE OPERATION WAS AN AORTA DISSECTION, WHICH WAS AN ACUTE SITUATION. THE TOTAL CPB TIME WAS 434 MINUTES, AT APPROXIMATELY 330 MINUTES THE LEAKAGE APPEARED. INITIALLY, A CO2-REMOVAL PROBLEM APPEARED DURING THE REWARDING PHASE OF THE SURGICAL PROCEDURE, INDICATING INCREASED GAS FLOW RATES AT GAS LINE PRESSURES ABOVE 25 MMHG. SUBSEQUENTLY, PLASMA LEAKAGE WAS NOTED AT THE GAS OUTLET PORT. THERE WAS DELAY DURING THE PROCEDURE; FOR THE NX19 NEEDED TO BE REPLACED DUE TO OXYGENATOR FAILURE. THE EXCHANGE WAS PERFORMED DURING A QUICK CIRCULATORY DISCONTINUATION OF 45 SECONDS. IMPACT ON THE SURGICAL PROCEDURE AS SUCH IS THEREFORE NOT ASSESSABLE. THE SURGERY WAS NOT COMPLETED, THE PATIENT EXPIRED ON THE OPERATING TABLE. THE PRODUCT WAS CHANGED OUT. THERE WAS A BLOOD LOSS OF APPROXIMATELY 185 ML.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12377223 ↗
• DeathJun 10, 2021Gas Output Problem; Leak/Splash; Gas Output Problem; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS A GAS TRANSFER PERFORMANCE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11973437 ↗
• MalfunctionJun 4, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, ABOUT 40 MINUTES ON PUMP, THERE WAS A PLASMA LEAK. THE PROCEDURE WAS FOR AORTIC VALVE REPLACEMENT AND ASCENDING GRAFT CONDUIT, REIMPLANTATION OF CORONARY ARTERY OSTIA ON GRAFT CONDUIT. THE PATIENTS BSA WAS 2.62. BLOOD FLOW WAS 6.15 LPM AND THE TEMPERATURE WAS 32C. THERE WERE NO ISSUES WITH GAS EXCHANGE PERFORMANCE AND DID NOT HAVE TO CHANGE OUT OXYGENATOR. FOAMING WAS SIGNIFICANT AND ASSOCIATED WITH VERY SMALL BLOOD LOSS. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. PRODUCT WAS NOT CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NEGLIGIBLE AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939912 ↗
• MalfunctionMay 14, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE OXYGENATOR HAD A PLASMA LEAK. PER USER FACILITY. THE OXYGENATOR STILL CONTINUED TO OXYGENATE AFTER THE PLASMA LEAK UNTIL THE FAILURE OF THE OXYGENATOR TO OXYGENATE AND REMOVE C02 (OXYGENATION FAILURE). THE PUMP TIME WAS UP TO 5 HOURS. THE SURGERY WAS COMING TO AN END SO THEY START VENTILATING WHEN IT COMPLETELY FAILED. NO KNOWN IMPACT OR CONSEQUENCES TO PATIENT. THE PRODUCT WAS NOT CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826680 ↗
• DeathApr 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THERE WAS A PLASMA LEAK. IT WAS A LONG PROCEDURE (364 MINUTES) WITH SEVERAL CHANGES BETWEEN OFF AND ON PUMP AND THE PERFUSIONIST CHANGED ALSO DURING THE PROCEDURE. IT WAS PLANNED TO BE A TAVI PROCEDURE WITHOUT ECC. THE PATIENT WAS IN A VERY BAD CONDITION AND HAD MULTIPLE CO-MORBIDITIES. DURING THE PROCEDURE THE NATIVE CIRCULATION COLLAPSED AND IT WAS DECIDED TO TAKE THE PATIENT ON BYPASS TO GIVE CIRCULATORY SUPPORT. THEY TRIED TO WEAN THE PATIENT SEVERAL TIME WITHOUT SUCCESS. THE PROCEDURE INCLUDED SEVERAL LOW FLOW PHASES AND ALSO INTERMITTENT TIME OF INTERNAL CIRCULATION OF THE HLM. THE PERFORMANCE OF THE OXYGENATOR WAS NOT AFFECTED. THE PATIENT EXPIRED. IT IS STILL UNKNOWN WHETHER THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT OR WHETHER THERE WAS BLOOD LOSS AS A RESULT OF THE PROCEDURE. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11733413 ↗
• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE CLINICIAN NOTICED A LEAK AT THE INLET WHILE PRIMING. *NO PATIENT INVOLVEMENT *PRODUCT WAS CHANGED OUT *PROCEDURE COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11070220 ↗
• MalfunctionSep 15, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT THERE A PLASMA LEAK. IT IS UNKNOWN WHEN THIS EVENT OCCURRED, 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: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 10536105 ↗
• MalfunctionJul 17, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THERE WAS A LEAK AT WATER CONNECTOR OF THE OXYGENATOR. NO PATIENT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 10290119 ↗

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-1346-2023 · Mar 1, 2023 · Open, Classified
  CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
• Z-2102-2019 · Jun 14, 2019 · Terminated
  Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
• 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-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