CAPIOX CX*FX05RWARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04987350739087), received between Jun 17, 2022 and Aug 19, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2025Crack; Crack

  THE USER FACILITY REPORTED THAT THERE WAS A SMALL CRACK IN THE BLOOD INLET PORT OF THE OXYGENATOR. THE EVENT OCCURRED DURING PRIME. THE EVENT DID NOT RESULT IN DELAYS WITH THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO BLOOD LOSS WAS REPORTED. THE EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839561 ↗
• MalfunctionFeb 25, 2025Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED AN OXYGENATOR ISSUE WITH THE DEVICE INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 21464987 ↗
• InjuryDec 20, 2024Use of Device Problem; Obstruction of Flow; Use of Device Problem; Obstruction of Flow

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE EVENT WAS RECOGNIZED BY THE HOSPITAL AS HUMAN ERROR, NOT A DEVICE MALFUNCTION. IT WAS STATED THAT THE ASSOCIATE SET THE PRESSURE LIMITS AT 575. IT WAS BELIEVED THAT HE OVERRODE THE SAFETY LIMITS, ALONG WITH OTHER ERRORS; THEREFORE, HE WAS LET GO.

  Patient problems: Insufficient Information

  MAUDE report 20989514 ↗
• MalfunctionJul 15, 2024Disconnection; Disconnection

  THE USER FACILITY REPORTED THAT THE SUCKER PRIME TUBING WAS DISCONNECTED. THE EVENT OCCURRED DURING PRE-CARDIOPULMONARY BYPASS. THE EVENT DID NOT RESULT IN A DELAY IN THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE EXACT TUBING WAS LIVANOVA. THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741730 ↗
• MalfunctionJul 15, 2024Disconnection; Disconnection

  THE USER FACILITY REPORTED THAT THE SUCKER PRIME TUBING WAS DISCONNECTED. THE EVENT OCCURRED DURING PRE-CARDIOPULMONARY BYPASS. THE EVENT DID NOT RESULT IN A DELAY IN THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE EXACT TUBING WAS LIVA NOVA. THE PRODUCT WAS NOT CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19741693 ↗
• MalfunctionJun 17, 2024Gas/Air Leak; Gas/Air Leak

  THE USER FACILITY REPORTED THAT DURING CARDIOPULMONARY BYPASS, AN AIR LEAK OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT EXCHANGING THE INVOLVED PRODUCT. THE EVENT RESULTED IN DELAY IN THE BEGINNING OR CONTINUING THE PROCEDURE. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY, AND NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547404 ↗
• MalfunctionFeb 21, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE USER FACILITY REPORTED AN ISSUE INVOLVING THE VENOUS THERMISTOR ON THE CAPIOX DEVICE INVOLVED. DURING SET-UP IT WAS NOTICED THAT IT WAS LOOSE. A TEMP PROBE WAS ATTACHED TO IT AND DID NOT GIVE A READING. AN ADDITIONAL OXYGENATOR WAS RETRIEVED AND WHEN IT WAS OPENED FROM THE INTERNAL WRAPPING, THE THERMISTOR OF THE SECOND OXYGENATOR FELL OFF COMPLETELY WITHOUT EVEN TOUCHING IT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE EVENT DID CAUSE OR CONTRIBUTE TO AN INJURY. NO BLOOD LOSS WAS REPORTED. THE PRODUCT WAS CHANGED OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 13 FEB 2024: THE EVENT DID RESULT IN DELAY IN BEGINNING OR CONTINUING OF THE SURGICAL PROCEDURE IN THE TIME IT TOOK TO CHANGE OUT THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749103 ↗
• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE OXYGENATOR INVOLVED LEAKED. AIR BUBBLES WERE PASSING ACROSS THE FIBER BUNDLE WHICH INDICATED A SEVERE FIBER LEAK. THE ISSUE OCCURRED DURING PRIMING. THE EVENT DID NOT RESULT IN DELAY IN THE BEGINNING OR CONTINUING OF THE SURGICAL PROCEDURE. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY OR DEATH. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566790 ↗
• MalfunctionMar 10, 2023Gas Output Problem; Pressure Problem; Gas Output Problem; Pressure Problem

  THE USER FACILITY REPORTED THAT OXYGENATOR DID NOT PERFORM TO ITS NORMAL FUNCTIONALITY, STRUGGLED TO GET THE PO2 ABOVE 80%. TWO PERFUSIONISTS WERE PRESENT DURING THE CASE. THEY CONTINUED TO USE THE OXY JUST ADDING MORE O2 WITH A PORTABLE O2 TANK. THEY HAD A DIFFICULT TIME GETTING THE PO2 ABOVE 80% WHEN WARMING. THE SURGERY DID NOT STOP. THE ISSUE WAS MITIGATED BY USING A 02 TANK. THE EVENT OCCURRED DURING A CARDIOPULMONARY BYPASS. THERE WAS NO DELAY IN THE PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT. THEY CONTINUED TO USE THE INVOLVED PRODUCT AND FINISHED THE CASE WITH IT. HOWEVER, THEY WERE UNABLE TO GET THE DESIRED PO2 WHILE USING IT DURING THE CASE. THE PATIENT WAS NOT HARMED AND NOT AFFECTED, AND NO BLOOD LOSS WAS REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 22 FEB 2023: THE PROCEDURE WAS A COMMON AV VALVE REPAIR, TAKEDOWN OF THE BIDIRECTIONAL GLENN, AND CENTRAL AORTOPULMONARY SHUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526786 ↗
• InjuryJun 17, 2022Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE INVOLVED WAS BEING USED DURING A CARDIOPULMONARY BYPASS PRODUCER WHEN THE OXYGENATOR FAILED. THE OXYGENATOR FAILURE DID NOT CAUSE OR CONTRIBUTE TO AN INJURY OR PATIENT DEATH. THE PATIENT WAS SEPTIC.

  Patient problems: Septic Shock

  MAUDE report 14737005 ↗