NIPRO Cellentia™-H Hemodialyzer Cellentia™-17HRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00383790004398), received between Dec 28, 2018 and Jun 3, 2026 — classified as 7 injuries, 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. 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 11 most recent of 11 reports, 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 ↗
• 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 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINIC MANAGER REPORTED A PATIENT WHO HAD DIALYZER REACTIONS ON UNSPECIFIED DATES SINCE (B)(6) 2018. PATIENT'S FIRST DIALYSIS WAS (B)(6) 2018. NO REACTIONS WERE ENCOUNTERED BETWEEN (B)(6) 2018. PATIENT WAS USING THE OPTIFLUX 180NRE. THE CLINIC MANAGER FIRST THOUGHT THE REACTION WAS DUE TO THE GLOVES, GLOVES WERE CHANGED AND THE PATIENT CONTINUED TO HAVE ALLERGIC REACTION. DIALYZER WAS THEN CHANGED TO THE OPTIFLUX 180NR, BUT THE PATIENT CONTINUED TO HAVE ALLERGIC REACTION. THE CLINIC MANAGER THEN CHANGED TO THE NIPRO CELLENTIA 17H ON (B)(6) 2018, THE PATIENT REPORTEDLY HAD A FEW SMALL HIVES AND SLIGHT ITCHING DURING MID-TREATMENT TO LAST HOUR OF TREATMENT. THE CLINIC MANAGER CONFIRMED THAT THE DIALYZER WAS FLUSHED WITH NORMAL SALINE SOLUTION PRIOR TO TREATMENT, PRIMING FLUSHING DIALYZER WITH 2 LITER NSS EVERY TREATMENT PER PHYSICIAN ORDERS AND CONFIRMED THAT BENADRYL WAS ADMINISTERED TO THE PATIENT INTRAVENOUSLY BOTH PRE-TREATMENT AND MID-TREATMENT. THE CLINIC MANAGER CONFIRMED THE PATIENT COMPLETED THEIR TREATMENTS, AND CONFIRMED THE PATIENT'S SYMPTOMS RESOLVE AFTER TREATMENT IS COMPLETED. LOT NUMBERS WERE NOT RECORDED. PATIENT CONTINUES TO HAVE REACTION BUT IS IMPROVED IN SEVERITY

  Patient problems: Itching Sensation; Rash; Reaction

  MAUDE report 8203581 ↗
• InjuryDec 28, 2018Patient-Device Incompatibility

  CLINIC MANAGER REPORTED A PATIENT WHO HAD DIALYZER REACTIONS ON UNSPECIFIED DATES SINCE (B)(6) 2018. PATIENT'S FIRST DIALYSIS WAS (B)(6) 2018. NO REACTIONS WERE ENCOUNTERED BETWEEN (B)(6) 2018 AND (B)(6) 2018. PATIENT WAS USING THE OPTIFLUX 180NRE. THE CLINIC MANAGER FIRST THOUGHT THE REACTION WAS DUE TO THE GLOVES, GLOVES WERE CHANGED AND THE PATIENT CONTINUED TO HAVE ALLERGIC REACTION. DIALYZER WAS THEN CHANGED TO THE OPTIFLUX 180NR, BUT THE PATIENT CONTINUED TO HAVE ALLERGIC REACTION. THE CLINIC MANAGER THEN CHANGED TO THE NIPRO CELLENTIA 17H ON (B)(6) 2018, THE PATIENT REPORTEDLY HAD A FEW SMALL HIVES AND SLIGHT ITCHING DURING MID-TREATMENT TO LAST HOUR OF TREATMENT. THE CLINIC MANAGER CONFIRMED THAT THE DIALYZER WAS FLUSHED WITH NORMAL SALINE SOLUTION PRIOR TO TREATMENT, PRIMING FLUSHING DIALYZER WITH 2 LITER NSS EVERY TREATMENT PER PHYSICIAN ORDERS AND CONFIRMED THAT BENADRYL WAS ADMINISTERED TO THE PATIENT INTRAVENOUSLY BOTH PRE-TREATMENT AND MID-TREATMENT. THE CLINIC MANAGER CONFIRMED THE PATIENT COMPLETED THEIR TREATMENTS, AND CONFIRMED THE PATIENT'S SYMPTOMS RESOLVE AFTER TREATMENT IS COMPLETED. LOT NUMBERS WERE NOT RECORDED. PATIENT CONTINUES TO HAVE REACTION BUT IS IMPR

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

  MAUDE report 8203353 ↗