CAPIOX®RX CX*RX05RWRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04987350763471), received between Dec 21, 2016 and Dec 9, 2024 — classified as 1 death, 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 9, 2024Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT AS SOON AS CPB START, THE AIR BUBBLES WERE FOUND AND COULD NOT BE REMOVED. A NEW DEVICE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HEALTH HAZARD TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878123 ↗
• MalfunctionNov 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE OCCURRED. DURING PRIMING, THE PERFUSIONIST FOUND LIQUID WAS COMING OUT OF THE GAS OUTLET. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVED/HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662081 ↗
• InjuryJul 31, 2024Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT DURING SURGERY, FIRST STAGE OXYGENATION DID NOT WORK IN THIS OXYGENATOR. AT THE SAME TIME, THE USER CHANGES THE OXYGENATOR PART ONLY AND THE RESERVOIR REMAINS THE SAME. AFTER THAT, THE OXYGENATION WORKS, AND THE SURGERY CONTINUES. GAS LINE/SUPPLY ARE OKAY. FIO2 IS ALSO SUFFICIENT. THE EVENT OCCURRED INTRA-OPERATIVELY. THE PATIENT'S FINAL IMPACT WAS NOT HARMED. NO PATIENT'S HARM WAS CAUSED BY THIS INCIDENT, BUT THE PRODUCT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19879304 ↗
• MalfunctionJan 31, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX LEAKAGE WAS NOTICED BY THE PERFUSIONIST WHEN THEY STARTED THE PRIMING OF THE OXYGENATOR BEFORE THE START OF SURGERY. THE CAPIOX WAS REPLACED WITH A FRESH AND THE SURGERY WAS NOT INTERRUPTED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614080 ↗
• MalfunctionNov 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED POOR OXYGENATION. IT WAS REPLACED WITH A NEW RX05; HOWEVER, THE OXYGENATION DID NOT IMPROVE. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193464 ↗
• MalfunctionNov 22, 2023Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED POOR OXYGENATION. IT WAS REPLACED WITH A NEW RX05; HOWEVER, THE OXYGENATION DID NOT IMPROVE. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193346 ↗
• MalfunctionMay 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT BLOOD SLOWLY DRIPS FROM THE GAS OUTLET DURING CPB, THE ENTIRE CPB PROCEDURE TAKES ABOUT ONE HOUR WITH A TOTAL OF SEVEN TO EIGHT DROPS. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015367 ↗
• MalfunctionJan 3, 2023Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED THAT SMALL BUBBLES WERE CONSTANTLY APPEARING ON THE TOP OF OXYGENATOR DURING THE CARDIOPULMONARY BYPASS (CPB) PROCEDURE PERFORMED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087978 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE SAMPLING LINE TUBE OF THE CAPIOX DEVICE INVOLVED FRACTURED AT THE JOINT WITH RESERVOIR PORT. THE FINAL PATIENT IMPACT WAS NOT HARMED. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391327 ↗
• MalfunctionSep 5, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE PERFUSIONIST FOUND WATER OUT OF GAS OUT PORT ON INVOLVED CAPIOX DEVICE DURING PRIMING. THE EVENT OCCURRED PRE-TREATMENT; THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 8964741 ↗
• MalfunctionAug 22, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THEY WERE SETTING UP FOR A TF CASE THAT REQUIRED THE USE OF BLOOD PRIME. THE SETUP INVOLVED THE TERUMO RX05 OXYGENATOR. THE CIRCUIT WAS SETUP AND PRIMED WITH PLASMALYTE-A, THEN 25% ALBUMIN, AND FINALLY PACKED RED BLOOD CELLS WERE ADDED TO THE CIRCUIT. AFTER THE BLOOD WAS ADDED THEY IMMEDIATELY OPENED THE HEMOCONCENTRATOR TO BEGIN REMOVING THE EXCESS CRYSTALLOID PRIME FROM THE CIRCUIT TO CONCENTRATE THE BLOOD. IT WAS NOTICED IMMEDIATELY THAT THE EFFLUENT SOLUTION WAS TINTED RED WHICH WAS REPORTED TO BE UNCOMMON FOR FIRST INITIAL USAGE OF THE DEVICE. THINKING THERE WAS AN ISSUE WITH THE DEVICE THEY SWITCHED OUT THE HEMOCONCENTRATOR FOR A NEW ONE. AFTER PRIMING THE DEVICE, THEY NOTED THE SAME RED TINTED EFFLUENT COMING FROM THE HEMOCONCENTRATOR. EQUATING IT TO POSSIBLY BEING AN OLDER UNIT OF BLOOD THAN NORMAL THEY CONTINUED TO REMOVE EXTRA CRYSTALLOID. AFTER ABOUT 30 MINUTES OF REMOVING CRYSTALLOID THEY NOTICED THERE WAS STILL AN AMOUNT OF VOLUME IN THE RESERVOIR AND IT WAS NOTED THAT THE CONCENTRATOR WAS TAKING A SIGNIFICANT AMOUNT OF TIME. THE SURGICAL FIELD AT THIS POINT WAS PREPPED AND DRAPED WITH LINES PASSED UP TO THE FIELD. THEY WERE STILL TRYING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920632 ↗
• InjuryMar 28, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE PERFUSIONIST CHANGED OUT THE CAPIOX OXYGENATOR; AFTER INITIATING THE BYPASS INITIAL PO2 WAS 250, AND AFTER THIRTY MINUTES PO2 DROPPED DOWN TO 45 MMHG. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS UNKNOWN. BLOOD LOSS WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 8458989 ↗
• MalfunctionMay 24, 2017Failure to Disconnect; Failure to Disconnect

  THE USER FACILITY REPORTED DIFFICULT IN DISCONNECTING THE OXYGENATOR FROM THE MANIFOLD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PRESSURE LINE THAT GOES FROM THE OXYGENATOR TO THE MANIFOLD WOULD NOT DISCONNECT, CONNECTION WAS BONDED CLOSED; THE EVENT HAPPENED DURING SET UP OF THE MACHINE; THE DEVICE WAS CHANGED OUT; THIS DID NOT CAUSE A DELAY IN THE PROCEDURE; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT WITH THE REPORTED DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6589695 ↗
• DeathApr 12, 2017Medical Gas Supply Problem; Medical Gas Supply Problem

  THE USER FACILITY REPORTED A PATIENT'S DEATH AFTER THE USE OF THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION FROM THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: THE PATIENT WAS RECEIVED WITH A NIRS OF 38-40% AND KEPT WITH A 2.5 L/MIN CARDIAC OUTPUT AND VENOUS FILTRATION; A COLD CARDIOPLEGIA WAS USED TO MAINTAIN THE MYOCARDIAL PROTECTION; A CAPIOX RX05 WAS USED; AFTER TWO HOURS AND FORTY MINUTES OF CARDIAC LUNG DERIVATION AN ARTERIAL BLOOD GAS LECTURE WAS TAKEN, PO2 OF 33 MMHG AND A SPO2 OF 85%; TUBING'S WERE CHECKED, A VENOUS BLOOD COLOR WAS PRESENT IN BOTH; NIRS INCREASES TO 68-70% AND ANESTHESIOLOGIST SUPPORTED WITH THE VENTILATION; TWO MINUTES LATER ANOTHER GAS LECTURE WAS TAKEN OBSERVING A DECREASE IN THE READINGS, PO2 OF 28 MMHG AND A SPO2 OF 75%; BECAUSE OF THIS THE CARDIAC LUNG DERIVATION IS STOPPED AND THE PROTOCOL FOR "OXYGENATOR FAILURE" IS FOLLOWED; THE OXYGENATOR WAS CHANGED OUT FOR A NEW ONE, LOT 160222; IN FIVE MINUTES THE NEW OXYGENATOR WAS SUCCESSFULLY INSTALLED; IMMEDIATELY AN APPROPRIATE GAS EXCHANGE WITH A PO2 OF 210 MMHG AND A SPO2 OF 100% WAS OBSERVED; THE PATIENT PRESENTED A SERIOUS HEMODYNAMIC AND RESPIRATORY DETERIORATION WITH A NIRS OF 38% AND DIED; FAIL

  Patient problems: Death

  MAUDE report 6485663 ↗
• InjuryDec 21, 2016Break; Break

  THE USER FACILITY REPORTED THAT THE OXYGENATOR DEVICE WAS FOUND TO HAVE BEEN BROKEN WHILE IN USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6194961 ↗