CAPIOX®RX CX*RX15RW30Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04987350771056), received between Feb 18, 2016 and Sep 9, 2020 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN THE PERFUSIONISTS WERE PRIMING THE CAPIOX OXYGENATOR PRE-TREATMENT, FLUID LEAKAGE WAS OBSERVED. THEY REPLACED IT WITH A NEW OXYGENATOR AND PROCEEDED WITH THE SURGERY. THE SAME RESERVOIR WAS USED FOR THE SURGERY. THE PATIENT IMPACT AND PROCEDURE OUTCOME WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507929 ↗
• MalfunctionAug 6, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED PRE-TREATMENT. AFTER THEY OPENED THE BOX, THE PERFUSIONIST FOUND ASEPTIC PACKAGE BROKEN. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 10372189 ↗
• MalfunctionAug 6, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED PRE-TREATMENT. AFTER THEY OPENED THE BOX, THE PERFUSIONIST FOUND ASEPTIC PACKAGE BROKEN. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS NOT REPORTED.

  Patient problems: No Information

  MAUDE report 10372187 ↗
• InjuryDec 23, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THEY DID NOT FIND ANYTHING UNUSUAL DURING PRIMING OF THE INVOLVED CAPIOX DEVICE; MAY BE THE FLOW RATE WAS SMALL. WHEN THEY STARTED CPB, THEY SAW THE VENOUS BLOOD OUT OF FROM THE UPPER SIDE OF VR FILTER AND FELT VENOUS BLOOD FLOW WAS NOT SMOOTH. THEY CHANGED THE ACTUAL RESERVOIR, AND EVERYTHING BECAME NORMAL. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509645 ↗
• MalfunctionDec 23, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE CONNECTION BETWEEN THE CAPIOX OXYGENATOR AND RESERVOIR WAS BROKEN. THE EVENT OCCURRED PRE-TREATMENT, AND THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509643 ↗
• MalfunctionNov 20, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE USER FACILITY REPORTED THAT THE USER STARTED PRIMING THE CAPIOX DEVICE BY RUNNING THE MAIN PUMP ABOUT 3-4L/MIN. DURING RECIRCULATING OF THE CARDIOPLEGIA LINE AT 250-300ML/MIN USING THE CARDIOPLEGIA PORT, THERE WAS EVIDENCE OF AN AIR BUBBLE THAT APPEARED IN MEMBRANE OXYGENATOR. THE USER IMMEDIATELY STOPPED THE PUMP AND CHANGED TO A NEW OXYGENATOR. THE USER PRIMED THE OXYGENATOR WITH DIFFERENT TECHNIQUE BY CONNECTING CARDIOPLEGIA LINE TO BLOOD OUTLET USING Y-CONNECTOR AND THERE WAS NO MORE EVIDENCE OF AIR BUBBLES. THE CASE WAS SUCCESSFUL, AND PATIENT WAS REPORTED TO BE SAFE. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346586 ↗
• MalfunctionOct 22, 2018Fracture; Fracture

  THE USER FACILITY REPORTED A FRACTURE WAS FOUND ON THE RECIRCULATION LINE JOINT, BEFORE PRIMING THE CAPIOX RX15 DEVICE. IT OCCURRED PRE-TREATMENT, AND THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7989766 ↗
• MalfunctionJul 6, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED WHEN THE PERFUSIONIST WAS OPENING THE IMMEDIATE CAPIOX DEVICE BOX FOR SURGERY, THEY SAW A SQUEEZED AREA IN THE BLOOD OUTLET AREA OF THE OXYGENATOR. THE EVENT OCCURRED PRE-TREATMENT AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Patient Involvement

  MAUDE report 7666176 ↗
• MalfunctionJun 19, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED WHEN THE PERFUSIONIST WAS OPENING THE IMMEDIATE CAPIOX DEVICE BOX FOR SURGERY, THEY SAW A SQUEEZED AREA IN THE BLOOD OUTLET AREA OF THE OXYGENATOR. THE EVENT OCCURRED PRE-TREATMENT AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Patient Involvement

  MAUDE report 7614118 ↗
• MalfunctionSep 29, 2017Break; Break

  THE USER FACILITY REPORTED BREAKAGE IN THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE OXYGENATOR WAS FOUND DETACHED FROM THE VENOUS RESERVOIR DURING THE CIRCULATION OF THE PRIME; THE CASE WAS VSD CLOSURE WITH MV REPAIR IN A CHILD; THE CASE WAS CARRIED OUT BY TYING THE OXYGENATOR TO THE RESERVOIR WITH GAUZE PIECES WHICH IS NOT A GOOD PRACTICE AS IT BECOMES A HINDRANCE TO THE VIEW OF THE PERFUSIONIST IN CASE OF ANY MALFUNCTION OR ACCIDENT DURING CPB; AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6904452 ↗
• MalfunctionFeb 3, 2017Break; Break

  THE USER FACILITY REPORTED BREAKAGE ON THE CAPIOX RX15 DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: WHEN THE PERFUSIONIST VISUALLY CHECKED THE OXYGENATOR, HE REALIZED THAT THE SUPPORT BETWEEN THE OXYGENATOR AND THE RESERVOIR WAS LOOSE AND THE OXYGENATOR WAS MOVING; THE PRODUCT WAS REPLACED AND A BACKUP UNIT WAS USED FOR THE PROCEDURE; THE REPORTED ISSUE WAS FOUND OUT OF BOX AND NOT USED IN A CASE; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6300205 ↗
• MalfunctionMay 12, 2016Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A LEAK IN THE CAPIOX RX15 DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: DURING THE PRIMING, THERE WAS A WATER LEAK IN BETWEEN THE RESERVOIR OUTLET AND THE REDUCER PROVIDED WITH THE OXYGENATOR; THE PATIENT WAS NOT HARMED; AND THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5649968 ↗
• InjuryApr 4, 2016Pressure Problem; Pressure Problem

  THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 FOR MFG. REPORT NO. 9681834-2016-00068 TO CORRECT THE INFORMATION THAT WAS INITIALLY REPORTED. THE BRAND NAME WAS INITIALLY REPORTED AS CAPIOX RF15, THE CORRECT BRAND NAME IS CAPIOX RX15.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 5545440 ↗
• MalfunctionFeb 18, 2016Leak/Splash; Leak/Splash

  THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 FOR MFG. REPORT NO. 9681834-2016-00015 TO PROVIDE THE RESULTS OF THE RETURNED DEVICE EVALUATION.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 5444127 ↗