NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-21HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00383790007122), received between Feb 20, 2019 and Mar 6, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  1.5 HOURS INTO DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. TREATMENT WAS INTERRUPTED AND PATIENT WAS MOVED TO A DIFFERENT MACHINE/SET-UP. APPROXIMATELY 250ML OF BLOOD LOSS. THE TEST STRIP WE USED WAS POSITIVE AND NO BLOOD WAS VISIBLE IN THE AFFLUENT DIALYSATE. WE HAD NO OTHER BLOOD LEAKS WITH THIS LOT NUMBER. ZOFRAN WAS ADMINISTERED TO THE PATIENT. THERE WERE NO MEDICAL INTERVENTIONS, HOWEVER PATIENT DID REQUIRE DIALYSIS ACCESS REVISION THE FOLLOWING DAY. DIALYSIS SETTINGS: BFR 350, DFR 600

  Patient problems: Insufficient Information

  MAUDE report 21537850 ↗
• MalfunctionMar 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  1.5 HOURS INTO DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD LEAK. TREATMENT WAS INTERRUPTED AND PATIENT WAS MOVED TO A DIFFERENT MACHINE/SET-UP. APPROXIMATELY 250ML OF BLOOD LOSS. THE TEST STRIP WE USED WAS POSITIVE AND NO BLOOD WAS VISIBLE IN THE AFFLUENT DIALYSATE. WE HAD NO OTHER BLOOD LEAKS WITH THIS LOT NUMBER. ZOFRAN WAS ADMINISTERED TO THE PATIENT. THERE WERE NO MEDICAL INTERVENTIONS, HOWEVER PATIENT DID REQUIRE DIALYSIS ACCESS REVISION THE FOLLOWING DAY. DIALYSIS SETTINGS: BFR 350, DFR 600.

  Patient problems: Insufficient Information

  MAUDE report 21537629 ↗
• MalfunctionApr 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  15 MINUTES INTO HDF DIALYSIS TREATMENT, STAFF NOTICED BLOODLEAK IN THE DIALYZER. MACHINE DID NOT ALARM FOR ANY ISSUES, ONLY VAM (VENOUS ACCES MONITOR) ALARM WAS NOTED. THE FACILITY TESTED FOR BLOOD LEAK AND RESULTS WERE POSITIVE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTED. PER FACILITY, PATIENT HAS BEEN USING THE ELISIO-H DIALYZERS FOR THE PAST 4 YEARS. THE PRIMING PROCEDURES WERE ACCORDING TO THE FRESENIUS MACHINE FOR ONLINE PRIMING. DIALYSIS SETTING SWERE HDF POST DILUTION. STILL PENDING ADDITIONAL INFORMATION FROM FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 19106768 ↗
• MalfunctionMay 27, 2021Obstruction of Flow; Obstruction of Flow

  CLINIC STATED THAT THEY HAVE EXPERIENCED AN INCREASE IN CLOTTED DIALYZERS SINCE SWITCHING FROM OPTIFLUX DIALYZERS TO ELISIO DIALYZERS. TREATMENTS ARE INTERRUPTED, AND MOST ARE UNABLE TO RETURN THE PATIENT'S BLOOD.THE CLOTTING IS NOT PATIENT, DIALYZER SIZE, OR USER SPECIFIC. 3 TOTAL INCIDENTS: (B)(6) 2021 - 1 INCIDENT (PATIENT REQUIRED BLOOD TRANSFUSION ON (B)(6) 2021) (B)(6) 2021 - 1 INCIDENT (B)(6) 2021 - 1 INCIDENT CLINICAL SPECIALIST CONTACTED THE FACILITY AND OFFERED IN-PERSON PRODUCT TRAINING FOR MAY 3, 4, AND 5TH 2021. CLINIC WAS ADVISED TO FOLLOW IFU FOR PROPER PRIMING INSTRUCTIONS, BECAUSE THE STAFF WAS FOLLOWING CLINIC PROTOCOLS AND NOT THE PRODUCT IFU. AFTER OUR CLINICAL SPECIALIST VISITED THE CLINIC AND OBSERVED THE STAFF DURING PRIMING AND RECIRCULATING PROCESS, IT WAS IDENTIFIED THAT THE CLINIC WAS RECIRCULATING WITH 100ML INSTEAD OF 200ML AS INSTRUCTED IN THE IFU. ARTERIAL CHAMBERS WERE ALSO OBSERVED NOT BE BE 75% FULL IN SOME CASES. DURING HER VISIT TO THE CLINIC, THE NURSE MANAGER ADVISED THAT A PATIENT REQUIRED A BLOOD TRANSFUSION 2 DAYS AFTER TREATMENT WAS INTERRUPTED AND THE PATIENT'S BLOOD COULD NOT BE RETURNED DUE TO THE CLOTTED DIALYZER. ALL DATA WAS DOCUMENTE

  Patient problems: Anemia

  MAUDE report 11899052 ↗
• MalfunctionMay 27, 2021Obstruction of Flow; Obstruction of Flow

  CLINIC STATED THAT THEY HAVE EXPERIENCED AN INCREASE IN CLOTTED DIALYZERS SINCE SWITCHING FROM OPTIFLUX DIALYZERS TO ELISIO DIALYZERS. TREATMENTS ARE INTERRUPTED, AND MOST ARE UNABLE TO RETURN THE PATIENT'S BLOOD. THE CLOTTING IS NOT PATIENT, DIALYZER SIZE, OR USER SPECIFIC. 3 TOTAL INCIDENTS: (B)(6) 2021- 1 INCIDENT (PATIENT REQUIRED BLOOD TRANSFUSION ON (B)(6) 2021); (B)(6) 2021- 1 INCIDENT; (B)(6) 2021- 1 INCIDENT. CLINICAL SPECIALIST CONTACTED THE FACILITY AND OFFERED IN-PERSON PRODUCT TRAINING FOR (B)(6) 2021. CLINIC WAS ADVISED TO FOLLOW IFU FOR PROPER PRIMING INSTRUCTIONS, BECAUSE THE STAFF WAS FOLLOWING CLINIC PROTOCOLS AND NOT THE PRODUCT IFU. AFTER OUR CLINICAL SPECIALIST VISITED THE CLINIC AND OBSERVED THE STAFF DURING PRIMING AND RECIRCULATING PROCESS, IT WAS IDENTIFIED THAT THE CLINIC WAS RECIRCULATING WITH 100ML INSTEAD OF 200ML AS INSTRUCTED IN THE IFU. ARTERIAL CHAMBERS WERE ALSO OBSERVED NOT BE 75% FULL IN SOME CASES. DURING HER VISIT TO THE CLINIC, THE NURSE MANAGER ADVISED THAT A PATIENT REQUIRED A BLOOD TRANSFUSION 2 DAYS AFTER TREATMENT WAS INTERRUPTED AND THE PATIENT'S BLOOD COULD NOT BE RETURNED DUE TO THE CLOTTED DIALYZER. ALL DATA WAS DOCUMENTED AND AN EMAI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899023 ↗
• InjuryDec 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, A 2ND PATIENT SENT TO THE ICU AFTER DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN DETAILS OF ADVERSE EVENT OR PATIENT SYMPTOMS. CLINICAL SPECIALIST WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 11/23/2020: PATIENT (B)(6); (B)(6)-YEAR-OLD FEMALE, STARTED DIALYSIS TREATMENT AT 630AM ON (B)(6) 2020, SET FOR 3.5H AS ORDERED, BP 104/65; HR 97. PATIENT COMPLAINED OF HEARTBURN DURING DIALYSIS. PATIENT STATED SHE HAS THIS OCCASIONALLY AT HOME AND TAKES SOME MEDS FOR IT. RENAL PHYSICIAN NOTIFIED OF PATIENT'S COMPLAINTS. PATIENT WAS STARTED ON OXYGEN 3L/NASAL CANNULA DUE TO COMPLAINTS OF SHORTNESS OF BREATH. O2(OXYGEN) SATURATION CHECKED, 100% WITH OXYGEN. PATIENT WAS RESTING DURING HD WITH NO FURTHER DISTRESS. AT APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT, RENAL PHYSICIAN WAS MAKING ROUNDS, SEEN AND EXAMINED PATIENT, WITH ORDERS TO STOP HD, DRAW LABS: CBC, LIPASE, TROPONIN, ELECTROLYTES AND SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION/TREATMENT. HD ENDED 2.5 HOURS INTO TREATMENT. NEEDLES WERE REMOVED WITH NO SEVERE BLEEDING. BP 118/68; HR 98; TEMP: 97.8. TREATMENT INFORMATION: NUMBER OF HOURS: 2.5 ACCES

  Patient problems: Abdominal Pain

  MAUDE report 10955690 ↗
• InjuryDec 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE 2ND PATIENT SENT TO THE ICU AFTER DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. UNKNOWN DETAILS OF ADVERSE EVENT OR PATIENT SYMPTOMS. CLINICAL SPECIALIST WILL CONTINUE TO ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED 11/23/2020: PATIENT (B)(6), A (B)(6)-YEAR-OLD FEMALE, STARTED DIALYSIS TREATMENT AT 630AM ON (B)(6) 2020, SET FOR 3.5H AS ORDERED, BP 104/65; HR 97. PATIENT COMPLAINED OF HEARTBURN DURING DIALYSIS. PATIENT STATED SHE HAS THIS OCCASIONALLY AT HOME AND TAKES SOME MEDS FOR IT. RENAL PHYSICIAN NOTIFIED OF PATIENT'S COMPLAINTS. PATIENT WAS STARTED ON OXYGEN 3L/NASAL CANNULA DUE TO COMPLAINTS OF SHORTNESS OF BREATH. O2(OXYGEN) SATURATION CHECKED, 100% WITH OXYGEN. PATIENT WAS RESTING DURING HD WITH NO FURTHER DISTRESS. AT APPROXIMATELY AN HOUR AND A HALF INTO TREATMENT, RENAL PHYSICIAN WAS MAKING ROUNDS, SEEN AND EXAMINED PATIENT, WITH ORDERS TO STOP HD, DRAW LABS: CBC, LIPASE, TROPONIN, ELECTROLYTES AND SENT TO EMERGENCY ROOM FOR FURTHER EVALUATION/TREATMENT. HD ENDED 2.5 HOURS INTO TREATMENT. NEEDLES WERE REMOVED WITH NO SEVERE BLEEDING. BP 118/68; HR 98; TEMP: 97.8. TREATMENT INFORMATION: NUMBER OF HOURS: 2.5 ACCE

  Patient problems: Abdominal Pain

  MAUDE report 10955687 ↗
• MalfunctionFeb 20, 2019Leak/Splash; Leak/Splash

  MACHINE ALARMED FOR BLOOD LEAK 15 MINUTES INTO DIALYSIS TREATMENT, BLOOD LEAK TEST STRIP WAS POSITIVE, TREATMENT STOPPED AND BLOOD WAS NOT RETURNED, PATIENT LOST ABOUT 200ML OF BLOOD. NEW MACHINE SET UP WAS STARTED, 5 MINUTES INTO DIALYSIS TREATMENT MACHINE ALARMED FOR BLOOD LEAK AGAIN AND TESTED BLOOD LEAK TEST STRIP WAS POSITIVE, TREATMENT WAS STOPPED, BLOOD WAS NOT RETURNED, PATIENT LOST ABOUT 200ML OF BLOOD AGAIN, A THIRD MACHINE SET UP WAS STARTED AGAIN, PATIENT FINISHED TREATMENT WITHOUT FURTHER PROBLEMS. SAME DIALZYER LOT NUMBER WAS USED FOR ALL 3 MACHINE SET UPS. SINCE THE BLOOD LEAK ALARMS, PATIENT HAS RETURNED FOR THEIR SCHEDULED DIALYSIS TREATMENTS WITHOUT COMPLICATIONS. DIALYSIS TREATMENT ORDER: 400 BLOOD FLOW RATE, 800 DIALYSATE FLOW RATE , TREATMENT TIME 4HRS AND 30MIN. OTHER DEVICES USED: DIALYSIS MACHINE: FRESENIUS T BLOODLINES: STREAMLINE.

  Patient problems: Blood Loss

  MAUDE report 8356034 ↗
• InjuryFeb 20, 2019Fluid/Blood Leak

  MACHINE ALARMED FOR BLOOD LEAK 15 MINUTES INTO DIALYSIS TREATMENT, BLOOD LEAK TEST STRIP WAS POSITIVE, TREATMENT STOPPED AND BLOOD WAS NOT RETURNED, PATIENT LOST ABOUT 200ML OF BLOOD. NEW MACHINE SET UP WAS STARTED, 5 MINUTES INTO DIALYSIS TREATMENT MACHINE ALARMED FOR BLOOD LEAK AGAIN AND TESTED BLOOD LEAK TEST STRIP WAS POSITIVE, TREATMENT WAS STOPPED, BLOOD WAS NOT RETURNED, PATIENT LOST ABOUT 200ML OF BLOOD AGAIN, A THIRD MACHINE SET UP WAS STARTED AGAIN, PATIENT FINISHED TREATMENT WITHOUT FURTHER PROBLEMS. SAME DIALZYER LOT NUMBER WAS USED FOR ALL 3 MACHINE SET UPS. SINCE THE BLOOD LEAK ALARMS, PATIENT HAS RETURNED FOR THEIR SCHEDULED DIALYSIS TREATMENTS WITHOUT COMPLICATIONS. DIALYSIS TREATMENT ORDER: 400 BLOOD FLOW RATE, 800 DIALYSATE FLOW RATE , TREATMENT TIME 4HRS AND 30MIN. OTHER DEVICES USED: DIALYSIS MACHINE: FRESENIUS T, BLOODLINES: STREAMLINE.

  Patient problems: Blood Loss

  MAUDE report 8355987 ↗