NIPRO ELISIO™ -H HEMODIALYZER ELISIO™-25HRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00383790007139), received between Jul 1, 2019 and May 27, 2021 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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. 7 TOTAL INCIDENTS REPORTED IN APRIL: ON (B)(6) 2021 - 1 INCIDENT, ON (B)(6) 2021 - 2 INCIDENTS, ON (B)(6) 2021 - 1 INCIDENT, ON (B)(6) 2021 - 1 INCIDENT, ON (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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898920 ↗
• MalfunctionMay 27, 2021Improper or Incorrect Procedure or Method; Output Problem; Priming Problem

  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. 7 TOTAL INCIDENTS REPORTED IN (B)(6): (B)(6) 2021 - 1 INCIDENT, (B)(6) 2021 - 2 INCIDENTS, (B)(6) 2021 - 1 INCIDENT, (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.

  Patient problems: Insufficient Information

  MAUDE report 11898833 ↗
• InjuryJul 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  1 HOUR INTO DIALYSIS TREATMENT, THE PATIENT COMPLAINED OF ITCHINESS AND HIVES WERE NOTED ON BOTH LOWER AND UPPER EXTREMITIES AND BACK. NO BENADRYL WAS GIVEN AND TREATMENT WAS DISCONTINUED AFTER 2 HRS OF TREATMENT, STAFF STATED ITCHINESS WAS BETTER BUT REDNESS STILL VISIBLE AND PATIENT WAS SENT HOME. PATIENT WILL RETURN ON SATURDAY JUNE 8, 2019 AND WILL BE PUT ON REXEED DIALYZER, WHICH WAS THE DIALYZER SHE WAS PREVIOUSLY USING. THE PHYSICIAN STATED THEY WILL GIVE THE PATIENT A WEEK REST AND WILL TRY AGAIN NEXT THURSDAY (6/13/19) ON ELISIO DIALZYER AGAIN BUT WILL PRIME THE ELISIO WITH MORE SALINE (1.5 L), AS THEY ALREADY PRIME THE ELISIO 25H WITH 1 L OF SALINE. PATIENT WAS GIVEN ARANESP 40 MCG, HECTOROL 1 MCG AND IRON 125 MG DURING TREATMENT, WHICH ARE NOT NEW MEDICATIONS FOR HER. DIALYSIS TREATMENT ORDER: PATIENT DIALYZED 3.5 HRS, BFR = 500, DFR = 800. HEPARIN WITH 1000 UNITS BOLUS AND 1000 UNITS/HR STOP 1 HR BEFORE END OF TREATMENT. ADDITIONAL INFORMATION RECEIVED 6/19/19: PATIENT IS DOING GOOD NOW WITH THE ELISIO DIALYZER, THE STAFF IS NOW PRIMING WITH 1.5 L OF SALINE AND PATIENT HAS NOT HAD ANY REACTIONS DURING TREATMENT. **** THIS IS THE SAME PATIENT THAT HAD A REACTION TO ELISI

  Patient problems: Increased Sensitivity; Itching Sensation; Local Reaction

  MAUDE report 8750977 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem

  1 HOUR INTO DIALYSIS TREATMENT, THE PATIENT COMPLAINED OF ITCHINESS AND HIVES WERE NOTED ON BOTH LOWER AND UPPER EXTREMITIES AND BACK. NO BENADRYL WAS GIVEN AND TREATMENT WAS DISCONTINUED AFTER 2 HRS OF TREATMENT, STAFF STATED ITCHINESS WAS BETTER BUT REDNESS STILL VISIBLE AND PATIENT WAS SENT HOME. PATIENT WILL RETURN ON (B)(6) 2019 AND WILL BE PUT ON REXEED DIALYZER, WHICH WAS THE DIALYZER SHE WAS PREVIOUSLY USING. THE PHYSICIAN STATED THEY WILL GIVE THE PATIENT A WEEK REST AND WILL TRY AGAIN NEXT THURSDAY ((B)(6) 2019) ON ELISIO DIALYZER AGAIN BUT WILL PRIME THE ELISIO WITH MORE SALINE (1.5 L), AS THEY ALREADY PRIME THE ELISIO 25H WITH 1 L OF SALINE. PATIENT WAS GIVEN ARANESP 40 MCG, HECTOROL 1 MCG AND IRON 125 MG DURING TREATMENT, WHICH ARE NOT NEW MEDICATIONS FOR HER. DIALYSIS TREATMENT ORDER: PATIENT DIALYZED 3.5 HRS, BFR = 500, DFR = 800. HEPARIN WITH 1000 UNITS BOLUS AND 1000 UNITS/HR STOP 1 HR BEFORE END OF TREATMENT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019: PATIENT IS DOING GOOD NOW WITH THE ELISIO DIALYZER, THE STAFF IS NOW PRIMING WITH 1.5 L OF SALINE AND PATIENT HAS NOT HAD ANY REACTIONS DURING TREATMENT. THIS IS THE SAME PATIENT THAT HAD A REACTION TO ELISIO (B)(6

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 8750954 ↗
• InjuryJul 1, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DURING DIALYSIS TREATMENT, THE PATIENT COMPLAINED OF ITCHINESS, REDNESS WAS NOTICED AT THE BACK OF HER NECK (2X2 CM). THE FACILITY ADMINISTRATOR MENTIONED THAT MAYBE THE REACTION WAS FROM THE NEW SHIRT THE PATIENT WAS WEARING. PATIENT WAS ABLE TO COMPLETE THE TREATMENT, BUT WHEN THE PATIENT REACHED HOME, THE PATIENT STATED THE ITCHINESS WORSENED AND NOTICED MORE REDNESS ON MULTIPLE AREAS. DIALYSIS TREATMENT ORDER: PATIENT DIALYZED 3.5 HRS, BFR = 500, DFR = 800. HEPARIN WITH 1000 UNITS BOLUS AND 1000 UNITS/HR STOP 1 HR BEFORE END OF TREATMENT. MEDS ADMINISTERED: HECTOROL 1 MG AND IRON 125 MG (HAS BEEN GIVEN THESE MEDICATIONS BEFORE WITHOUT ISSUES). ADDITIONAL INFORMATION RECEIVED 6/19/19: PATIENT IS DOING GOOD NOW WITH THE ELISIO DIALYZER, THE STAFF IS NOW PRIMING WITH 1.5 L OF SALINE AND PATIENT HAS NOT HAD ANY REACTIONS DURING TREATMENT.

  Patient problems: Increased Sensitivity; Itching Sensation; Local Reaction

  MAUDE report 8750934 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem

  DURING DIALYSIS TREATMENT, THE PATIENT COMPLAINED OF ITCHINESS, REDNESS WAS NOTICED AT THE BACK OF HER NECK (2X2 CM). THE FACILITY ADMINISTRATOR MENTIONED THAT MAYBE THE REACTION WAS FROM THE NEW SHIRT THE PATIENT WAS WEARING. PATIENT WAS ABLE TO COMPLETE THE TREATMENT, BUT WHEN THE PATIENT REACHED HOME, THE PATIENT STATED THE ITCHINESS WORSENED AND NOTICED MORE REDNESS ON MULTIPLE AREAS. DIALYSIS TREATMENT ORDER: PATIENT DIALYZED 3.5 HRS, BFR = 500, DFR = 800. HEPARIN WITH 1000 UNITS BOLUS AND 1000 UNITS/HR STOP 1 HR BEFORE END OF TREATMENT. MEDS ADMINISTERED: HECTOROL 1 MG AND IRON 125 MG (HAS BEEN GIVEN THESE MEDICATIONS BEFORE WITHOUT ISSUES). ADDITIONAL INFORMATION RECEIVED 6/19/2019: PATIENT IS DOING GOOD NOW WITH THE ELISIO DIALYZER, THE STAFF IS NOW PRIMING WITH 1.5 L OF SALINE AND PATIENT HAS NOT HAD ANY REACTIONS DURING TREATMENT.

  Patient problems: Erythema; Itching Sensation; Reaction

  MAUDE report 8750890 ↗