NIPRO Cellentia-H HemodialyzerRecalls & reported problems across all models

We found 4 models of NIPRO Cellentia-H Hemodialyzer by Nipro Medical Corporation in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Dec 28, 2018 and Jun 3, 2026 — classified as 2 deaths, 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported NIPRO Cellentia-H Hemodialyzer problems

NIPRO Cellentia-H Hemodialyzer models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NIPRO Cellentia™-H Hemodialyzer Cellentia™-17H

  Dialyzer, high permeability with or without sealed dialysate system
  11 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-21H

  Dialyzer, high permeability with or without sealed dialysate system
  6 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-15H

  Dialyzer, high permeability with or without sealed dialysate system
  2 deaths2 reports
• NIPRO Cellentia™-H Hemodialyzer Cellentia™-19H

  Dialyzer, high permeability with or without sealed dialysate system
  2 reports

Recent NIPRO Cellentia-H Hemodialyzer adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Patient-Device Incompatibility

  PATIENT HAS BEEN DIALYZING WITH THE USE OF NIPRO CELLENTIA 17H DIALYZER AS PRESCRIBED SINCE APPROXIMATELY (B)(6) 2025. PATIENT COMPLAINED OF SEVERE ITCHING ON (B)(6) 2025, PATIENT WAS ADMINISTERED BENADRYL 50 MG IVP. NIPRO CELLENTIA 17H DISCONTINUED AND ADDED AS AN ALLERGY. ADDITIONAL INFORMATION RECEIVED 02/25/2026: THE PATIENT WAS USING AN 180NRE OPTIFLUX DIALYZER ON (B)(6) 2025. THE DIALYZER WAS CHANGED TO OPTIFLUX 180NR ON (B)(6) 2026. THEN THE PATIENT WAS CHANGED AGAIN, TO THE CELLENTIA 17H ON (B)(6) 2025 (NO RATIONALE PROVIDED). THE AFFECTED LOT NUMBER IS 25D21E. BENADRYL, BOTH ORAL AND IV, WAS PRESCRIBED AND ADMINISTERED DURING THE TREATMENT, BUT IT DID NOT RESOLVE THE ITCHING. THE PATIENT REPORTED SEVERE ITCHING APPROXIMATELY 40 TO 60 MINUTES INTO TREATMENT, WHICH CONTINUED EVEN AFTER THE PATIENT RETURNED HOME. THE ITCHING SUBSIDED THE FOLLOWING DAY WHEN THE PATIENT DID NOT RECEIVE TREATMENT. THE PATIENT ARRIVED AT THE CLINIC WITHOUT ANY VISIBLE SIGNS OR SYMPTOMS OF ITCHING.

  Patient problems: Itching Sensation

  MAUDE report 25383716 ↗
• InjuryJun 3, 2026Patient-Device Incompatibility

  PATIENT HAS BEEN DIALYZING WITH THE USE OF NIPRO CELLENTIA 17H DIALYZER AS PRESCRIBED SINCE APPROXIMATELY (B)(6) 2025. PATIENT COMPLAINED OF SEVERE ITCHING ON (B)(6) 2025, PATIENT WAS ADMINISTERED BENADRYL 50 MG IVP. NIPRO CELLENTIA 17H DISCONTINUED AND ADDED AS AN ALLERGY.

  Patient problems: Itching Sensation

  MAUDE report 25382972 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  MW5168729 RECEIVED VIA EMAIL WITH THE FOLLOWING: IT WAS REPORTED TO (B)(6) VIA EMAIL THAT CELLENTIA HEMODIALYZER - SINGLE USE 17H HAD A BLOOD LEAK OCCURRENCE AT START OF TREATMENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). NO CUSTOMER INFORMATION IS AVAILABLE TO REACH OUT TO THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION RELATE TO THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24158064 ↗
• InjuryMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED BLOOD LEAK OCCURRENCE AS SOON AS THE TREATMENT STARTED, MACHINE ALARMED FOR BLOOD LEAK RIGHT AWAY. NO MEDICATIONS WERE GIVEN, NO PATIENT SYMPTOMS PRESENT, NO MEDICAL INTERVENTION REQUIRED. BLOOD WAS NOT VISIBLE, NO DEFECT OR DAMAGE DETECTED ON THE DIALYZER. BLOOD LEAK TEST STRIP WAS NEGATIVE. TREATMENT INTERRUPTED, APPROXIMATELY 200ML OF BLOOD LOSS. NEW MACHINE WAS SET UP WITH NEW SUPPLIES. PATIENT COMPLETED TREATMENT. DIALYSIS MACHINE: 2008T, FRESENIUS BLOODLINE USED, DIALYSATE FLOW RATE (DFR): AUTOFLOW 1.5, BLOOD FLOW RATE (BFR): 300. GENDER: MALE, WEIGHT: 93KG, DIAGNOSIS: AKI (ACUTE KIDNEY INJURY), PATIENT HAS BEEN ON DIALYSIS 3 TIMES A WEEK SINCE (B)(6) 2025.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985373 ↗
• MalfunctionMay 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED BLOOD LEAK OCCURRENCE AS SOON AS THE TREATMENT STARTED, MACHINE ALARMED FOR BLOOD LEAK RIGHT AWAY. NO MEDICATIONS WERE GIVEN, NO PATIENT SYMPTOMS PRESENT, NO MEDICAL INTERVENTION REQUIRED. BLOOD WAS NOT VISIBLE, NO DEFECT OR DAMAGE DETECTED ON THE DIALYZER. BLOOD LEAK TEST STRIP WAS NEGATIVE. TREATMENT INTERRUPTED, APPROXIMATELY 200ML OF BLOOD LOSS. NEW MACHINE WAS SET UP WITH NEW SUPPLIES. PATIENT COMPLETED TREATMENT. DIALYSIS MACHINE: 2008T, FRESENIUS BLOODLINE USED, DIALYSATE FLOW RATE (DFR): AUTOFLOW 1.5, BLOOD FLOW RATE (BFR): 300 GENDER: MALE, WEIGHT: 93KG, DIAGNOSIS: AKI (ACUTE KIDNEY INJURY), PATIENT HAS BEEN ON DIALYSIS 3 TIMES A WEEK SINCE (B)(6) 2025.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984879 ↗
• InjuryDec 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ATTENDED REGULARLY SCHEDULED IN-CENTER DIALYSIS TREATMENT. PRE VITAL SIGNS BP-149/82, PULSE-101, RESPIRATION-21, TEMPERATURE - 97.8. AT APPROX 0954 DIALYSIS WAS INITIATED WITH A USE OF TREATMENT ENDED, PATIENT GIVEN DIPHENHYDRAMINE 50 MG IVP(INTRAVENOUS PUSH). PATIENT DEVELOPED SHORTNESS OF BREATH, SLURRED SPEECH AND RIGHT FACIAL DROOP. 911 CALLED, PATIENT TRANSPORTED TO HOSPITAL VIA EMS(EMERGENCY MEDICAL SERVICES) AND LATER RELEASED. PATIENT RETURNED TO FACILITY (B)(6) 2023, TREATED ON OPTIFLUX 180NR DIALYZER WITHOUT INCIDENT. NIPRO CELLENTIA 21 ADDED AS ALLERGY.

  Patient problems: Dysphasia; Dyspnea

  MAUDE report 18389304 ↗
• InjuryDec 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ATTENDED REGULARLY SCHEDULED IN-CENTER DIALYSIS TREATMENT. PRE VITAL SIGNS BP-149/82, PULSE-101, RESPIRATION-21, TEMPERATURE - 97.8. AT APPROX 0954 DIALYSIS WAS INITIATED WITH A USE OF TREATMENT ENDED, PATIENT GIVEN DIPHENHYDRAMINE 50 MG IVP(INTRAVENOUS PUSH). PATIENT DEVELOPED SHORTNESS OF BREATH, SLURRED SPEECH AND RIGHT FACIAL DROOP. 911 CALLED, PATIENT TRANSPORTED TO HOSPITAL VIA EMS(EMERGENCY MEDICAL SERVICES) AND LATER RELEASED. PATIENT RETURNED TO FACILITY (B)(6) 2023, TREATED ON OPTIFLUX 180NR DIALYZER WITHOUT INCIDENT. NIPRO CELLENTIA 21 ADDED AS ALLERGY.

  Patient problems: Dysphasia; Dyspnea

  MAUDE report 18388822 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  2HOURS AND 30 MINUTES INTO HEMODIALYSIS TREATMENT, MACHINE ALARMED. TREATMENT STOPPED, BLOOD LEAK CONFIRMED WITH BLOOD LEAK TEST STRIP. NO VISIBLE BLOOD ON DIALYZER. BLOOD WAS NOT RETURNED, UNDETERMINED AMOUNT OF BLOOD LOSS, ESTIMATED MINIMAL. NO MEDICAL INTERVENTIONS OR HOSPITALIZATION. PRIMING CONDITIONS: BFR=150ML/MIN AND PRIMING VOLUME=1000ML. DIALYSIS CONDITIONS: TX TIME=3HRS, BFR=350ML/MIN, DFR=SEQUENTIAL (UF ONLY), ACCESS= AVF WITH 16G NEEDLE 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573241 ↗
• MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  2HOURS AND 30 MINUTES INTO HEMODIALYSIS TREATMENT, MACHINE ALARMED. TREATMENT STOPPED, BLOOD LEAK CONFIRMED WITH BLOOD LEAK TEST STRIP. NO VISIBLE BLOOD ON DIALYZER. BLOOD WAS NOT RETURNED, UNDETERMINED AMOUNT OF BLOOD LOSS, ESTIMATED MINIMAL. NO MEDICAL INTERVENTIONS OR HOSPITALIZATION. PRIMING CONDITIONS: BFR=150ML/MIN AND PRIMING VOLUME=1000ML. DIALYSIS CONDITIONS: TX TIME=3HRS, BFR=350ML/MIN, DFR=SEQUENTIAL (UF ONLY), ACCESS= AVF WITH 16G NEEDLE 1"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569515 ↗
• InjurySep 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  CHARGE RN STATED THAT CELLENTIA WAS PRIMED WITH 250 NS AND PATIENT TREATMENT STARTED. WITHIN 5 MINUTES OF TREATMENT START, PATIENT COMPLAINED OF FEELING FAINT AND SHORT OF BREATH. CHARGE NURSE STATED THAT THEY STOPPED THE TREATMENT AND DID NOT RETURN BLOOD TO PATIENT. STAFF REPORTED THAT NO MEDICATIONS WERE GIVEN TO THE PATIENT AND THE PATIENT VITAL SIGNS WERE STABLE. PATIENT REQUESTED TO GO TO THE EMERGENCY ROOM AND AMBULANCE WAS CALLED. PATIENT WAS DISCHARGED FROM HOSPITAL AND RETURNED TO THE OUTPATIENT CLINIC ON WEDNESDAY (B)(6) 2022 AT WHICH TIME SHE HAD A DIALYSIS TREATMENT USING CELLENTIA DD AGAIN AND COMPLETED THE TREATMENT WITHOUT ANY COMPLAINTS. PATIENT HAS BEEN USING CELLENTIA 17 DIALYZERS FOR A YEAR NOW AND THIS IS THE FIRST TIME SHE COMPLAINED OF PROBLEMS.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 15431374 ↗
• InjurySep 15, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  CHARGE RN STATED THAT CELLENTIA WAS PRIMED WITH 250 NS AND PATIENT TREATMENT STARTED. WITHIN 5 MINUTES OF TREATMENT START, PATIENT COMPLAINED OF FEELING FAINT AND SHORT OF BREATH. CHARGE NURSE STATED THAT THEY STOPPED THE TREATMENT AND DID NOT RETURN BLOOD TO PATIENT. STAFF REPORTED THAT NO MEDICATIONS WERE GIVEN TO THE PATIENT AND THE PATIENT VITAL SIGNS WERE STABLE. PATIENT REQUESTED TO GO TO THE EMERGENCY ROOM AND AMBULANCE WAS CALLED. PATIENT WAS DISCHARGED FROM HOSPITAL AND RETURNED TO THE OUTPATIENT CLINIC ON WEDNESDAY (B)(6) 2022 AT WHICH TIME SHE HAD A DIALYSIS TREATMENT USING CELLENTIA DD AGAIN AND COMPLETED THE TREATMENT WITHOUT ANY COMPLAINTS. PATIENT HAS BEEN USING CELLENTIA 17 DIALYZERS FOR A YEAR NOW AND THIS IS THE FIRST TIME SHE COMPLAINED OF PROBLEMS.

  Patient problems: Dyspnea; Syncope/Fainting

  MAUDE report 15430976 ↗
• InjuryMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT/ 3 OCCURRENCES WITH THE SAME LOT # REPORTED. PATIENT LOST BLOOD WITH THE 1ST OCCURRENCE. THE 2ND AND 3RD OCCURRENCE OCCURRED PRIOR TO INITIATING TREATMENT, THE MACHINE KEPT ALARMING FOR AIR. ON THE 3RD OCCURRENCE STAFF CHANGED THE DIALYZER WITH A DIFFERENT LOT # AND TREATMENT WAS COMPLETED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 03/02/2021: PRIMING CONDITIONS: THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. DIALYSIS CONDITIONS: BFR 400, DFR: 800, TREATMENT TIME 4 HRS AND NO HEPARIN. BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER: GAMBRO MACHINE AND LINES. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER: 300 ML. WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. WHERE DID THE BUBBLES GENERATE MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558920 ↗
• InjuryMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT / 2 OCCURRENCES: WHERE THE STAFF HAVE NOTICED MASSIVE AIR BUBBLES IN THE DIALYZER, STAFF DID WHATEVER THEY COULD BUT WERE NOT ABLE TO CLEAR THE BUBBLES AND HAD TO WASTE THE PATIENT'S BLOOD. ADDITIONAL INFORMATION RECEIVED 03/02/2021: PRIMING CONDITIONS - THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. DIALYSIS CONDITIONS: BFR 400, DFR: 800, TREATMENT TIME 4 HRS AND NO HEPARIN BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER: GAMBRO MACHINE AND LINES. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER - 300 ML WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. WHERE DID THE BUBBLES GENERATE: MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558902 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT/ 3 OCCURRENCES WITH THE SAME LOT # REPORTED. PATIENT LOST BLOOD WITH THE 1ST OCCURRENCE. THE 2ND AND 3RD OCCURRENCE OCCURRED PRIOR TO INITIATING TREATMENT, THE MACHINE KEPT ALARMING FOR AIR. ON THE 3RD OCCURRENCE STAFF CHANGED THE DIALYZER WITH A DIFFERENT LOT # AND TREATMENT WAS COMPLETED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED 03/02/2021: 1. PRIMING CONDITIONS - THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. 2. DIALYSIS CONDITIONS - BFR 400, DFR - 800, TREATMENT TIME 4 HRS AND NO HEPARIN. 3. BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER - GAMBRO MACHINE AND LINES. 4. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER - 300 ML. 5. WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. 6. WHERE DID THE BUBBLES GENERATE - MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558883 ↗
• MalfunctionMar 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  1 PATIENT / 2 OCCURRENCES - WHERE THE STAFF HAVE NOTICED MASSIVE AIR BUBBLES IN THE DIALYZER, STAFF DID WHATEVER THEY COULD BUT WERE NOT ABLE TO CLEAR THE BUBBLES AND HAD TO WASTE THE PATIENT'S BLOOD. ADDITIONAL INFORMATION RECEIVED 03/02/2021: 1. PRIMING CONDITIONS - THEY PRIME WITH A BFR OF 100 AND FLUSHED THE DIALYZER WITH AT LEAST A L OF SALINE. 2. DIALYSIS CONDITIONS - BFR 400, DFR - 800, TREATMENT TIME 4 HRS AND NO HEPARIN. 3. BRAND/MANUFACTURER NAME & MODELS OF DEVICES USED TOGETHER WITH DIALYZER - GAMBRO MACHINE AND LINES. 4. HOW MUCH BLOOD DID THE PATIENT LOST DUE TO CHANGING THE DIALYZER - 300 ML. 5. WAS ANY MEDICAL ACTIONS TAKEN- NONE AS THEIR HGB (AS CLAIMED WHEN THEY RECHECKED) WAS STABLE. 6. WHERE DID THE BUBBLES GENERATE - MIDDLE TO TOP PORTION OF THE DIALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11558860 ↗

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