CAPIOX®FX CX*FX15WRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987350701206), received between Feb 10, 2016 and May 12, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Failure to Deliver

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE OXYGENATOR DID NOT FUNCTION PROPERLY DURING A LUNG TRANSPLANT WHEN THEY WENT ON BYPASS. THE LUNG WAS ALREADY OUT OF THE BODY; THEREFORE, THEY INCREASED THEIR SWEEP TO 10 TO LIMP BY UNTIL THEY TRANSITIONED TO CARDIO HELP. THEREFORE, THEY DID NOT CHANGE THE OXY OUT. THERE WAS NO DELAY OR INJURY OR PATIENT DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149808 ↗
• MalfunctionJul 23, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT PLASMA LEAKED FROM THE INVOLVED OXYGENATOR. THE EVENT OCCURRED DURING CARDIOPULMONARY BYPASS. IT WAS UNKNOWN IF THE EVENT RESULTED IN DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT AND IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO AN INJURY. IT WAS UNKNOWN IF THERE WAS ANY BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807686 ↗
• MalfunctionSep 10, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE HAD A POOR OXYGENATOR PERFORMANCE. THE PROBLEM OCCURRED DURING A CARDIOPULMONARY BYPASS. THERE WAS NO DELAY IN THE BEGINNING OR CONTINUING THE SURGICAL PROCEDURE. THE PRODUCT WAS NOT CHANGED OUT. THERE WAS NO BLOOD LOSS BECAUSE OF THE REPORTED ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717143 ↗
• InjurySep 23, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE OXYGENATOR DEVICE INVOLVED HAD HIGH RPM AND LOW FLOW ON CENTRIFUGAL. THERE WAS DECREASED SV02 AND DECREASE CEREBRAL SATS. FIRST, USER CHANGED OUT CENTRIFUGAL MOTOR AND THERE WAS NO CHANGE. THEN, THE DEVICE WAS THEN SWITCHED OUT AND THE NEW OXYGENATOR PERFORMED AS EXPECTED. TO BE DETERMINED AFTER WAKING AND NEURO CHECK. NO PRE OR POST OXYGEN PRESSURE WAS MEASURED. THE SURGERY WAS COMPETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 19 SEP 2022: THE EVENT OCCURRED DURING BYPASS. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO AN INJURY OR DEATH. BLOOD LOSS WAS LESS THAN 100CC'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474740 ↗
• MalfunctionMar 15, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE PRIME LINE LEAKED ON THE CAPIOX DEVICE DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION; THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6407354 ↗
• MalfunctionAug 25, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A TUBE FRACTURE ON THE CAPIOX FX15 DEVICE DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: TODAY AFTER WE DROPPED PRIME IN THE CIRCUIT WE INITIATED FLOW TO PRIME THE AV LOOP; IMMEDIATELY WE NOTICED LEAKAGE AT THE TOP OF THE OXYGENATOR AT THE PURGE LINE; WE CHANGED IT OUT IMMEDIATELY AND REPLACED WITH ANOTHER FX15; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5904054 ↗
• MalfunctionAug 2, 2016Fracture; Fracture

  THE USER FACILITY REPORTED A TUBE FRACTURE ON THE CAPIOX FX15 DEVICE DURING PRIME. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE ONE WAY VALVE LINE CONNECTED TO THE OXYGENATOR LOOKS LIKE IT HAD BEEN SEVERED; THE PRODUCT WAS CHANGED OUT; THE SURGERY WAS COMPLETED SUCCESSFULLY; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5840971 ↗
• MalfunctionFeb 10, 2016Device Damaged Prior to Use; Device Damaged Prior to Use

  THE USER FACILITY REPORTED THAT DURING PRIME THE SAMPLING LINE CONNECTION AT THE ARTERIAL LINE OUTLET WAS DAMAGED ON THE CAPIOX FX15 DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: (1) THE OXYGENATOR WAS CHANGED OUT BEFORE THE CASE; (2) SURGERY WAS COMPLETED SUCCESSFULLY; AND (3) THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5427165 ↗