CAPIOX®RX CX*RX15RW40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04987350771094), received between Mar 21, 2018 and Jan 28, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Failure to Deliver; Failure to Deliver

  THE USER FACILITY REPORTED THAT LOW OXYGENATION OCCURRED. THE INCIDENT OCCURRED WHEN THE PATIENT WAS ON BYPASS (CARDIOVASCULAR). THE ARTERIAL BLOOD WAS NOTICEABLY DARK AFTER BYPASS; ROUGHLY TEN MINUTES DESPITE INCREASING FIO2, BLOOD AND GAS FLOW. ARTERIAL BLOOD GAS (ABG) WAS PERFORMED AND FOUND THAT THE PO2, PCO2 AND LACTIC ACID WAS HIGH. ABG WAS PERFORMED AFTER FIO2, GAS AND CPB FLOWS WAS MAXIMIZED WITH MARGINAL IMPROVEMENT. THE OXYGENATOR WAS CHANGED AND PERFORMED. ALL PARAMETERS IMPROVED WITH STANDARD FIO2 AND CPB FLOW. THE EVENT IS DEEMED AS SERIOUS SINCE THE DEVICE WAS REPLACED; HOWEVER, THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252318 ↗
• MalfunctionJul 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT FOUR (4) HOURS AFTER CPB WAS STARTED, THE PERFUSIONIST DISCOVERED BLOODY FLUIDS HAD LEAKED OUT OF THE GAS OUTLET OF THE INVOLVED OXYGENATOR, LOTS OF BUBBLES APPEARED. THERE WAS NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721722 ↗
• MalfunctionDec 26, 2018Break; Break

  THE USER FACILITY REPORTED BREAKAGE ON THE INVOLVED CAPIOX DEVICE. DURING THE DEVICE SETUP AND PRIMING, THE PIPE CONNECTION OF THE MANIFOLD WAS DISCOVERED TO BE CRUMPLED. A BACKUP WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE REPORTED DEFECTED PRODUCT DID NOT CONTRIBUTE TO INJURY. THE FINAL PATIENT IMPACT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8195385 ↗
• InjuryJun 19, 2018Pressure Problem; Pressure Problem

  THE USER FACILITY REPORTED A HIGH PRESSURE DROP IN THE ABSENCE OF GAS EXCHANGE ALTERATION ON THE INVOLVED CAPIOX DEVICE. ENTERED IN BYPASS WITH PATIENT IN VENTRICULAR FIBRILLATION, HEPARIN DONE DURING FV AND IT ADDED IN THE PRIME (10.000 U/I). AFTER 10 MINUTES ON BY PASS WITH A FLOW OF 4900 ML / MIN AND ACT HIGHER THAN 480 THERE WAS AN INCREASE OF OXY INLET PRESSURE (440 MMHG) AND A NORMAL OUTLET PRESSURE (70 MMHG) WITHOUT ALTERATION OF THE GASEOUS EXCHANGES (GAS BLENDER FIO2 AT 60% AND 2.5 L / M OF AIR). ALL THE MEASURES ENVISAGED TO DECREASE THE PRESSURE DROP (ADD OF ALBUMIN AND SODIUM NITROPRUSSIDE) DID NOT HAVE ANY RESULTS SO IT WAS DECIDED TO DECREASE THE TEMPERATURE AND REPLACE THE OXYGENATOR. BLOOD LOSS WAS REPORTED TO BE 400 ML. THE PROCEDURE OUTCOME IS UNKNOWN. FINLA PATIENT IMPACT IS UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 7613665 ↗
• InjuryMar 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE FAILED OXYGENATION. THE OXYGENATOR WAS PRIMED PER PROTOCOL AND PRE-BYPASS CHECKLIST WAS DONE BEFORE BYPASS. STARTED BYPASS AT 11.30 AM AFTER ACTIVATED CLOTTING TIME (ACT) WAS MORE THAN 1000 SEC. FOUR MINUTES INTO BYPASS, THE USER NOTICED THAT THE ARTERIAL BLOOD WAS DARK AND INFORMED SURGEON AND ANESTHETIST. OXYGEN SOURCES WERE CHECKED AND CONFIRMED. CASE OF CABG X 4 (LIMA). THE OXYGENATOR WAS CHANGED WITH ANOTHER RX15RW40 AND BYPASS WAS RE-INITIATED WITHOUT ANY PROBLEM WITH OXYGENATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT WAS REPORTED TO BE SAFE. WHEN THE ACTUAL SAMPLE WAS CHANGED OUT, SOME BLOOD WAS LOST BUT THE EXACT AMOUNT OF LOST BLOOD IS UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 7357263 ↗