CAPIOX®RX CX*RX25RERecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04987350769558), received between Jul 8, 2016 and Aug 5, 2021 — classified as 3 injuries, 14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Decrease in Pressure; Decrease in Pressure

  THE USER FACILITY REPORTED THAT PRE-TREATMENT; WHILE THE USER WAS PRIMING THE CAPIOX DEVICE, THE PRESSURE OF THE OXYGENATOR OR CIRCUIT DECREASED. THEY FOUND THAT THE OXYGENATOR'S ARTERIAL TUBING VALUE DOWNING DURING THE PRIMING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12279498 ↗
• MalfunctionNov 7, 2019Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE CAPIOX CARDIOTOMY RESERVOIR DETACHED FROM THE OXYGENATOR, DUE TO THE BONDING CLIP THAT CAME OFF FROM THE OXYGENATOR. IT HAPPENED BEFORE BYPASS; DURING BYPASS CIRCUIT SETUP. THEY USED ANOTHER RX25 OXYGENATOR FROM STOCK TO MANAGE THAT CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9289603 ↗
• MalfunctionDec 11, 2018Break; Break

  THE USER FACILITY REPORTED BREAKAGE ON THE INVOLVED CAPIOX RX25 DEVICE. THE OUTLET WAS DEFORMED. DURING INSTALLATION OF THE EQUIPMENT, THE PERFUSIONIST EVIDENCED THAT THE GAS OUTLET LUER IS HIDDEN AT LESS THAN 50% AND HE CONSIDERS THAT THE OXYGENATOR IS NOT IN ADEQUATE CONDITIONS FOR USE. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150019 ↗
• MalfunctionJul 11, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THE OXYGENATOR DURING OPERATION WAS NOT NORMAL. A LOT OF BUBBLE CAME OUT DURING BYPASS. THEY ADJUSTED THE GAS FLOW, AND USED A DEFOAMING AGENT TO REDUCE THE BUBBLE. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679281 ↗
• MalfunctionJul 11, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THE AIR BUBBLES IN THE OXYGENATOR. THERE WERE NO ANOMALIES REPORTED TO BE SEEN ON THE OXYGENATOR WHEN USER OPENED THE BOX. THE USER STARTED PRIMING (NO PATIENT WAS INVOLVED) AS USUAL, HE DID PRESSURIZE TEST OF 250MMHG AND AFTER 10-15 MINUTES THE EVIDENCE OF AIR BUBBLE APPEARED. THE GAS BLENDER WAS OFF DURING PRIMING. HE STOPPED RUNNING THE PUMP AND CHANGED TO NEW OXYGENATOR. HE RAN THE PUMP AGAIN AND PROCEEDED WITH THE CASE. THE CASE WAS SUCCESSFUL BY USING THE NEW OXYGENATOR AND PATIENT WAS REPORTED TO BE SAFE. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT WAS NOT HARMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7676800 ↗
• MalfunctionJun 13, 2018Device Operational Issue; Device Operational Issue

  THE USER FACILITY REPORTED AIR BUBBLING ON THE INVOLVED CAPIOX DEVICE. THERE ARE NO ANOMALIES REPORTED TO BE SEEN ON THE OXYGENATOR WHEN USER OPENED THE BOX. THE USER STARTED PRIMING (NO PATIENT WAS INVOLVED) AS USUAL AROUND 9AM. BY 9.30AM, IT WAS NOTICED THAT BUBBLES BEGAN TO APPEAR IN THE ARTERIAL FILTER WHICH SUDDENLY LEAD TO THE WHOLE CIRCUIT INCLUDING OXYGENATOR AND BEGAN TO FILL UP WITH BUBBLES. IT WAS REPORTED THAT THEY DO CONNECT THE GAS SUPPLY WHEN THEY PRIME. IT WAS REPORTED THAT ACCORDING TO THEM, IT MAY HELP TO CLEAR THE MICRO DEBRIS. IT WAS REPORTED THAT THEY DID NOT USE A HEMOCONCENTRATOR FOR THIS CASE. THE CASE WAS SUCCESSFUL BY USING THE NEW OXYGENATOR AND PATIENT WAS REPORTED TO BE SAFE AND WAS NOT HARMED.

  Patient problems: No Patient Involvement

  MAUDE report 7595530 ↗
• MalfunctionMay 31, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED A FLOW RESTRICTION ON THE INVOLVED CAPIOX DEVICE. THE WATER LEVEL OF THE ARTERIAL LINE RECEDED. THE CORRECT OPERATION OF THE PUMP, THE INTEGRITY OF THE FILTER AND THE LINES WERE VERIFIED, FINDING THEM IN GOOD CONDITION. IN ADDITION, BUBBLES WERE SEALED INSIDE THE OXYGENATOR. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556187 ↗
• MalfunctionMar 21, 2018Bent; Bent

  THE USER FACILITY REPORTED THAT THE WATER OUT PORT WAS BENT ON THE INVOLVED CAPIOX DEVICE AND WAS FOUND PRE-TREATMENT. PROCEDURE OUTCOME IS UNKNOWN. FINAL PATIENT IMPACT IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7357262 ↗
• MalfunctionFeb 15, 2018Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS LEAKING OXYGENATOR GAS TO THE BLOOD. CONTINUED USE AS THE OXYGEN SATURATES AND ARTERIAL GASES WERE WITHIN RANGE. CLINICAL OPINION IS THAT IF BYPASS TIME WAS EXTENDED THEN OXYGENATOR CHANGE WOULD HAVE BEEN NECESSARY, AS THE RATE OF LEAK WAS INCREASING. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273550 ↗
• MalfunctionSep 27, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX DEVICE PRIOR TO A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: UPON PRIMING THE DEVICE THE PERFUSIONIST NOTICED A LEAK OF VOLUME FROM THE RECIRCULATION LINE OF THE MANIFOLD TO NEAR THE VENOUS RETURN INLET; THE PRIME LINE WAS REPORTED TO HAVE BEEN BROKEN; THE PERFUSIONIST CHANGED THE RESERVOIR AND OXYGENATOR; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6896803 ↗
• MalfunctionApr 14, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THE CAPIOX DEVICE LEAKED. FOLLOW UP COMMUNICATION REPORTED THE FOLLOWING INFORMATION: THE PERFUSIONIST CONDUCTED THE OCCLUSION SETTING AND CALIBRATION, PRIOR TO THE START OF BYPASS CARDIOPULMONARY; THE DROP LEVEL WAS OBSERVED TO BE INCORRECT; THE PERFUSIONIST TRIED TO VERIFY THE LEAK IN THE TUBING, BUT NO LEAK WAS NOTED; THE ACTUAL DEVICE WAS CHANGED OUT; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6492940 ↗
• MalfunctionNov 22, 2016Medical Gas Supply Problem; Medical Gas Supply Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE OXYGENATOR WAS USED IN A CASE WHERE THE PATIENT WAS RECEIVING CARDIAC SURGERY. THE PERFUSIONIST REPORTED THAT THE DEVICE WASN´T EFFICIENTLY OXYGENATING DURING THAT SPECIFIC CASE IN THE CARDIAC SURGERY. THERE HAVE BEEN SIMILAR CASES OVER THE LAST THREE (3) MONTHS. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6122744 ↗
• MalfunctionNov 22, 2016Air Leak; Air Leak

  THE USER FACILITY REPORTED AIR BUBBLING IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE FLOW WAS TURNED DOWN ONCE PRIMED; VISIBLE AIR WAS DRAWN ACROSS THE MEMBRANE; THE STEP WAS REPEATED AT A MUCH SLOWER SPEED WHEN THE PUMP WAS TURNED BY HAND; ONCE AGAIN, VISIBLE AIR WAS DRAWN ACROSS THE MEMBRANE; THERE WAS NO PRESSURE LOSS FROM CIRCUIT AND NO EVIDENCE OF A LEAK WHEN PRESSURIZED; AT THIS TIME THERE WAS NO PATIENT INVOLVEMENT; THE DEVICE WAS CHANGED OUT BEFORE THE PROCEDURE; AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 6122601 ↗
• MalfunctionNov 22, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING PRIMING, THE PERFUSIONIST SAW A LEAK FROM THE VENOUS RESERVOIR, MAINLY AT THE ENTRANCE; THE OXYGENATOR WAS CHANGED; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6122447 ↗
• InjuryOct 25, 2016Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED ON OCTOBER 27, 2016 STATES THE FOLLOWING: A LEAK WAS DETECTED AT THE END OF THE PROCEDURE, DURING REWARMING; 500ML BLOOD LOSS WAS REPORTED; THE OXYGENATOR LEAKED ON THE TOP BETWEEN THE HOUSING AND RECIRCULATION LINE; REMEDIAL ACTION WAS TAKEN TO ADD BONE WAX ON THE LEAKAGE POINT; THE OXYGENATOR WAS NOT EXCHANGED; THE PROCEDURE WAS CONTINUED AND PATIENT TREATED AS INTENDED, NO SIGNIFICANT DELAY; THE PATIENT HAS MAINTAINED PRESSURE VALUES DURING THE ISSUE AND WAS NOT AFFECTED BY HAEMODYNAMIC DAMAGES OF ANY KIND; AND THE PATIENT WAS TREATED FOR AORTIC STENOSIS +CAD, CUSTOMER REPORTED TO MOH.

  Patient problems: Blood Loss

  MAUDE report 6053450 ↗
• InjuryJul 8, 2016Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE ON THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING THE PROCEDURE, AT THE START OF EXTRACORPOREAL CIRCULATION, A MALFUNCTION OF THE OXYGENATOR WAS DETECTED; IT WAS REPORTED ECC STARTED AT 10:51; RIGHT AFTER THE START IN ECC, A SERIOUS PROBLEM OF ARTERIAL DESATURATION HAD BEEN OBSERVED; CONSIDERING THE HEMODYNAMIC STABILITY OF THE PATIENT, THE CUSTOMER DECIDED TO STOP THE ECC IN ORDER TO PREPARE A NEW OXYGENATOR; DURING THE PREPARATION OF THE NEW TERUMO OXYGENATOR A SEVERE HYPOTENSION UNRESPONSIVE TO INOTROPIC AND FILLING OCCURRED, IT WAS DECIDED TO START AGAIN IN ECC; IT WAS REPORTED THAT THE BLOOD APPEARED VISIBLY DESATURATED; THE CUSTOMER DECIDED TO PROCEED TO CHANGE OUT THE OXYGENATOR WITH A NEW TERUMO OXYGENATOR; ONCE THE CUSTOMER STARTED ECC AGAIN WITH THE NEW OXYGENATOR TERUMO, THE SAME PROBLEM OCCURRED AGAIN; THEREFORE, THE CUSTOMER DECIDED TO CHANGE OUT THE OXYGENATOR ONCE AGAIN, REPLACING IT WITH A MAQUET OXYGENATOR; IT WAS REPORTED AFTER THE CHANGE OUT THAT THERE WERE NO PROBLEMS ENCOUNTERED RELATED TO OXYGENATION; IT WAS REPORTED THAT THE SCHEDULED SURGERY TH

  Patient problems: Blood Loss

  MAUDE report 5778175 ↗
• InjuryJul 8, 2016Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED INSUFFICIENT GAS EXCHANGE ON THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING THE PROCEDURE, AT THE START OF EXTRACORPOREAL CIRCULATION, A MALFUNCTION OF THE OXYGENATOR WAS DETECTED; IT WAS REPORTED ECC STARTED AT 10:51; RIGHT AFTER THE START IN ECC, A SERIOUS PROBLEM OF ARTERIAL DESATURATION HAD BEEN OBSERVED; CONSIDERING THE HEMODYNAMIC STABILITY OF THE PATIENT, THE CUSTOMER DECIDED TO STOP THE ECC IN ORDER TO PREPARE A NEW OXYGENATOR; DURING THE PREPARATION OF THE NEW TERUMO OXYGENATOR A SEVERE HYPOTENSION UNRESPONSIVE TO INOTROPIC AND FILLING OCCURRED, IT WAS DECIDED TO START AGAIN IN ECC; IT WAS REPORTED THAT THE BLOOD APPEARED VISIBLY DESATURATED; THE CUSTOMER DECIDED TO PROCEED TO CHANGE OUT THE OXYGENATOR WITH A NEW TERUMO OXYGENATOR; ONCE THE CUSTOMER STARTED ECC AGAIN WITH THE NEW OXYGENATOR TERUMO, THE SAME PROBLEM OCCURRED AGAIN; THEREFORE, THE CUSTOMER DECIDED TO CHANGE OUT THE OXYGENATOR ONCE AGAIN, REPLACING IT WITH A MAQUET OXYGENATOR; IT WAS REPORTED AFTER THE CHANGE OUT THAT THERE WERE NO PROBLEMS ENCOUNTERED RELATED TO OXYGENATION; IT WAS REPORTED THAT THE SCHEDULED SURGERY TH

  Patient problems: Blood Loss

  MAUDE report 5778169 ↗