REXEED 25SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04537693003927), received between Jul 19, 2018 and Jan 23, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2019, THIS PATIENT STARTED THE TREATMENT WITH DIALYZER, REXEED-25S. AFTER 30 MINUTES FROM THE BEGINNING OF THE TREATMENT, ONE SIDE OF THE ARTERIAL HEADER OF THE DIALYZER HOUSING LIFTED UP, AND THE BLOOD STARTED COMING OUT OF THE DIALYZER. THEREFORE, THE PATIENT'S TREATMENT NEEDED TO BE STOPPED URGENTLY. ALL BLOOD IN THE CIRCUIT WAS UNABLE TO BE RETURNED TO THE PATIENT. THE VOLUME OF THE PATIENT'S BLOOD LOSS WAS ABOUT 230 ML.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9619907 ↗
• MalfunctionApr 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  (B)(6) 2019, THIS EVENT OCCURRED DURING THE TREATMENT WITH REXEED-25S. THIS CLINIC PRIMED WITH 1000 ML OF NORMAL SALINE AND RECIRCULATED THE DIALYZER FOR ABOUT 5 MINUTES. AFTER 90 MINUTES FROM THE TREATMENT START, THE VENOUS PRESSURE ALARMED, AND THEN THE BLOOD LEAK FROM THE ARTERIAL HEADER OCCURRED. AFTER THIS EVENT, THIS PATIENT'S CONDITION WAS STABLE, AND THE PATIENT DID NOT REQUIRE MEDICAL ATTENTION, THERE WAS NEITHER NEED FOR BLOOD TRANSFUSION NOR FOR ADJUSTING ERYTHROPOIETIN(EPO) DOSAGE. THE PATIENT LEFT THE DIALYSIS ROOM IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525800 ↗
• InjuryNov 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT WAS IN OUTPATIENT DIALYSIS UNIT FOR REGULARLY SCHEDULED DIALYSIS TREATMENT 3 DAYS A WEEK. PATIENT WAS PRESCRIBED A TREATMENT LENGTH OF 4 HR 15 MINUTES. DIALYSATE FLOW RATE WAS 800 ML/MIN AND DIALYSATE TEMPERATURE 36 C. PATIENT'S DRY WEIGHT WAS (B)(6), HE WAS SET FOR A TARGET LOSS OF 3.4 KG. ON (B)(6) 2018, 06:55, DIALYSIS OF REXEED-25S WAS INITIATED. ON (B)(6) 2018, APPROXIMATELY 07:25, PATIENT'S ALARM ON MACHINE STARTED SOUNDING WITH AN ARTERIAL PRESSURE ALARM. NURSE WENT OVER TO MACHINE, AND IT APPEARED THAT BLOOD AND LIQUID WAS COMING OUT OF THE ARTERIAL HANSEN DRIPPING ONTO TO FLOOR (HIS APPROXIMATE BLOOD VOLUME LOSS: ROUGHLY 100 CC). PUMP WAS STOPPED, AND PATIENT WAS DISCONNECTED. RINSE BACK WAS NOT GIVEN. MACHINE WAS CHANGED OUT. THE PATIENT'S HEALTH CONDITION WAS STABLE, AND DID NOT NEED ANY MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050028 ↗
• MalfunctionAug 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6), 2018, THE PATIENT WAS GIVEN THE TREATMENT WITH HEMODIALYSIS (HD) USING REXEED-25S. AT 12:15 PM, THE TREATMENT WAS STARTED. THE PATIENT WAS VERY RESTLESS AND HAD SHORTNESS OF BREATH FROM THE BEGINNING OF HIS TREATMENT. DESPITE HIS RESTLESSNESS, HIS CATHETER WAS RUNNING WITHOUT ANY PROBLEM AND MACHINE WAS NOT FREQUENTLY ALARMING. AT 13:56 PM, THE PATIENT REQUESTED TO GET OUT OF HIS BED AND TRANSFER TO THE DIALYSIS CHAIR SO THE NURSE DISCONNECTED THE PATIENT FROM THE DIALYSIS SYSTEM AND PUT THE SYSTEM INTO RECIRCULATION. AT 14:05 PM, THE MACHINE ALARMED DUE TO HIGH VENOUS PRESSURE, THE NURSE PRESSED THE RESET KEY TO RESTART THE MACHINE. UPON THE BLOOD PUMP STARTING, THE NURSE HEARD A CRACK AND BLOOD STARTED POURING OUT OF THE TOP OF THE DIALYZER. THE TREATMENT WAS STOPPED AND THE PATIENT CONTINUED TREATMENT WITH NEW PRIMED DIALYZER WITHOUT INCIDENT. PATIENT CONDITION WAS STABLE.

  Patient problems: Dyspnea; No Code Available

  MAUDE report 7831291 ↗
• MalfunctionJul 19, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2018, THE PATIENT WAS GIVEN THE TREATMENT WITH HEMODIALYSIS (HD) USING REXEED-25S. A NURSE PLACED NEEDLES IN FISTULA WITHOUT PROBLEMS, AND STARTED THE TREATMENT. ARTERIAL PRESSURE ALARMED MULTIPLE TIMES APPROXIMATELY 5-7 MINUTES INTO THE TREATMENT AND THE NURSE ATTEMPTED TO ADJUST THE NEEDLE WITHOUT SUCCESS. THE NURSE STARTED TO RECIRCULATE TO TRY TO ADJUST THE NEEDLES. SINCE ARTERIAL PRESSURE ALARMED ON THE DIALYSIS MACHINE, THE NURSE DID NOT CHECK IF THE BLOOD WAS CLOTTED WHEN THE MACHINE WAS RECIRCULATED. AS SOON AS MACHINE WAS STARTED TO RECIRCULATE, BLOOD CLOTS WERE COMING OUT OF THE ARTERIAL HEAD OF THE DIALYZER. AFTER FURTHER INVESTIGATION, IT WAS DISCOVERED THAT PATIENT'S ACCESS WAS CLOTTED AND THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY TO REMOVE BLOOD CLOTS. PATIENT DID NOT HAVE ANY ISSUES WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701652 ↗