NXSTAGE CARTRIDGE EXPRESS CAR-172-CRecalls & reported problems
Nxstage Medical, Inc. · Class 2
All models of NXSTAGE CARTRIDGE EXPRESS (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NxStage Cartridge Express is a dialyzer cartridge used in hemodialysis treatment. Its 102 FDA reports include 52 injuries and no deaths, and often describe fluid or blood leaking from the cartridge, allergic-type reactions, low blood pressure, and bleeding during treatment. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI M535CAR172C0), received between Sep 14, 2018 and Aug 12, 2026 — classified as 52 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (46 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak46
- Adverse Event Without Identified Device or Use Problem38
- No Apparent Adverse Event18
- Break11
- Patient-Device Incompatibility3
- Detachment of Device or Device Component2
- Improper or Incorrect Procedure or Method2
- Device Slipped1
Patient problems
- Hemorrhage/Blood Loss/Bleeding34
- Hypersensitivity/Allergic reaction26
- Low Blood Pressure/ Hypotension22
- Dyspnea15
- No Clinical Signs, Symptoms or Conditions12
- Dizziness10
- Nausea9
- Blood Loss6
Recent adverse event reports
The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
A report was received on (b)(6)2026 from a healthcare professional (HCP) of a 66 year old female patient with a medical history including diabetes, hypertension, obesity, and end stage renal disease, who stated the patient experienced rhinitis, coughing, hypotension, and hypoglycemia during a hemodialysis treatment on (b)(6)2026.Additional information was received on 23 Jul 2026 from the HCP stating the patient also experienced lacrimation of her eyes and pruritus. The patient was referred to an allergist. There was no report of medical intervention being required.
Patient problems: Cough; Excessive Tear Production; Hypersensitivity/Allergic reaction; Hypoglycemia; Low Blood Pressure/ Hypotension; Rhinitis
MAUDE report 50219898 ↗InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 19 MAR 2026 FROM THE NURSE OF AN 83-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF DIABETES, STATING THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS FOR APPROXIMATELY ONE MINUTE AFTER INITIATING HER FIRST HOME HEMODIALYSIS TREATMENT WITH THE DEVICE ON (B)(6) 2026. THE PATIENT ALSO EXPERIENCED A DECREASE IN SYSTOLIC BLOOD PRESSURE FROM 190 TO 115 MMHG SYSTOLIC, NAUSEA, AND REDNESS IN THE FACE AND UPPER BODY. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED BUT THE PATIENT WAS NOT TRANSPORTED TO HOSPITAL AS SYMPTOMS RESOLVED UPON EMS ARRIVAL. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAR-2026 FROM A HEALTHCARE PROFESSIONAL (HCP) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL SYMPTOMS AND THERE WAS NO MEDICAL INTERVENTION REQUIRED. PER THE HCP, THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND HAS NOT RESUMED THERAPY WITH NXSTAGE.
Patient problems: Erythema; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Nausea; Syncope/Fainting
MAUDE report 24756154 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON (B)(6) 2026 FROM THE NURSE OF A 35-YEAR-OLD MALE PATIENT, STATING THE PATIENT EXPERIENCED CHEST PAIN, DIFFICULTY BREATHING AND HOT FLASHES DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2026. 100MG INTRAVENOUS HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE) WAS ADMINISTERED AND THE SYMPTOMS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026 FROM THE NURSE WHO STATED THE PATIENT HAS RECOVERED AND WILL NOT RESUME THERAPY WITH NXSTAGE.
Patient problems: Chest Pain; Dyspnea; Hot Flashes/Flushes; Hypersensitivity/Allergic reaction
MAUDE report 24653485 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2026 FROM A 65-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD LEAKED FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 06 FEB 2026 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24365356 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 19 NOV 2025 FROM THE NURSE OF A 69-YEAR-OLD MALE PATIENT WITH UNSPECIFIED PATHOLOGY STATING THE PATIENT EXPERIENCED AN ALLERGIC REACTION (NOS) DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 24 NOV 2025 FROM THE NURSE WHO STATED THAT THE PATIENT BECAME UNRESPONSIVE AT THE START OF A HEMODIALYSIS TREATMENT. THE PATIENT AWOKE, COMPLAINED OF ITCHING AND WAS ADMINISTERED NOREPINEPHRINE, DIPHENHYDRAMINE, EPINEPHRINE AND 2.5 LITERS OF SALINE BEFORE BEING TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR MONITORING.
Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Loss of consciousness
MAUDE report 23767560 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 28 OCT 2025 FROM THE HEALTH CARE PROFESSIONAL (HCP) OF A 46 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HYPOTENSION (~70/40 MMHG), SHORTNESS OF BREATH, A DECREASE IN OXYGEN SATURATION (88%), ITCHING AND A RASH AT THE BEGINNING OF AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2025. TREATMENT WAS STOPPED AND THE PATIENT WAS ADMINISTERED A SALINE FLUSH, OXYGEN, INTRAVENOUS (IV) ANTIHISTAMINE, AND CORTICOSTEROID (SPECIFIC DOSES AND NAMES NOT PROVIDED). ADDITIONAL INFORMATION WAS RECEIVED ON 03 NOV 2025 FROM THE HCP WHO STATED THE PATIENT ALSO RECEIVED AN UNSPECIFIED DOSE OF IV EPINEPHRINE, RECOVERED WITHOUT SEQUELAE, AND HAS RESUMED HEMODIALYSIS WITH THE USE OF A DIALYZER FROM A DIFFERENT MANUFACTURER.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Rash
MAUDE report 23584174 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 18 SEP 2025 FROM A HEALTH CARE PROFESSIONAL (HCP) REGARDING AN 81-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED ITCHING, COUGHING, PALPITATIONS AND LARYNGOSPASM APPROXIMATELY 3 MINUTES AFTER STARTING THEIR FIRST HEMODIALYSIS TREATMENT WITH THE NXSTAGE DEVICE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 01 OCT 2025 FROM THE HEALTH CARE PROFESSIONAL (HCP) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL SYMPTOMS RELATED TO THE ISSUE AND NO MEDICAL INTERVENTION WAS REQUIRED. PER THE HCP, THE PATIENT RECOVERED WITHOUT SEQUELAE AND WILL NOT CONTINUE TREATMENT WITH NXSTAGE.
Patient problems: Cough; Hypersensitivity/Allergic reaction
MAUDE report 23294878 ↗MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 18 JUL 2025 FROM THE CAREGIVER OF A 33 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD LEAKED FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 18 JUL 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22727200 ↗MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 09 JUN 2025 FROM A HEALTHCARE PROFESSIONAL REGARDING AN 82 YEAR OLD MALE, WHO STATED THE PATIENT BECAME HYPOTENSIVE APPROXIMATELY FIFTEEN MINUTES FROM THE END OF A HEMODIALYSIS TREATMENT ON (B)(6) 2025, AND AN UNSPECIFIED AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED ON 12 JUN 2025 FROM THE LOCAL SAFETY OFFICER (LSO) WHO STATED THERE WAS NO ADVERSE IMPACT TO THE PATIENT, AND THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22376239 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 29 MAY 2025 FROM THE NURSE OF A 64-YEAR-OLD FEMALE PATIENT, WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HYPOTENSION, ITCHING, SWEATING, NAUSEA, FOAMING OF THE MOUTH AND BECAME UNRESPONSIVE DURING AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2025. OXYGEN, DIPHENHYDRAMINE (BENADRYL) 50 MG AND INTRAVENOUS METHYLPREDNISOLONE (SOLU MEDROL) 125 MG WERE ADMINISTERED. EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED FROM 04-06 JUN 2025 FROM THE NURSE WHO STATED THE PATIENT WAS OBSERVED OVERNIGHT AND RELEASED ON (B)(6) 2025. PER THE NURSE, THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND RETURNED TO CONVENTIONAL HEMODIALYSIS TREATMENT.
Patient problems: Diaphoresis; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Nausea; Salivary Hypersecretion; Skin Inflammation/ Irritation
MAUDE report 22327405 ↗MalfunctionMar 20, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
A REPORT WAS RECEIVED ON (B)(6) 2025 FROM A 70-YEAR-OLD MALE WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21652952 ↗InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 13 FEB 2025 FROM THE NURSE OF A 48-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED IN THE WASTE LINE DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2025. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS DIAGNOSED WITH HEMOLYSIS. ADDITIONAL INFORMATION WAS RECEIVED ON 24 FEB 2025 FROM THE HOME THERAPY NURSE (HTN), WHO STATED THE PATIENT EXPERIENCED BLOOD IN HER URINE, CHEST PAIN AND HYPERTENSION. PER THE HTN, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AND DISCHARGED IN STABLE CONDITION ON (B)(6) 2025. FOLLOWING THE EVENT, THE PATIENT HAS RECOVERED WITHOUT SEQUALAE AND RESUMED TREATMENT WITH THE NXSTAGE SYSTEM.
Patient problems: Chest Pain; Hematuria; Hemolysis; High Blood Pressure/ Hypertension
MAUDE report 21561293 ↗MalfunctionJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2025 FROM A 45 YEAR OLD MALE WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21255190 ↗MalfunctionJan 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2025 FROM THE HOME THERAPY NURSE (HTN) OF A 51 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 FROM THE HTN WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21222989 ↗MalfunctionJan 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 26 DEC 2024 FROM A 55-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 30 DEC 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21199136 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 20 DEC 2024 FROM THE HOME THERAPY NURSE (HTN) OF A 36 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION, ASTHMA AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED INCREASED HEART RATE, SWOLLEN FACE AND LABORED BREATHING DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 20 AND 23 DEC 2024 FROM THE HTN WHO STATED THE CAREGIVER ENDED TREATMENT, PATIENT WAS GIVEN ORAL DIPHENHYDRAMINE (BENADRYL), EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION ON (B)(6) 2024.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Swelling/ Edema; Tachycardia
MAUDE report 21138289 ↗MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2024 FROM A 52 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21127117 ↗MalfunctionDec 6, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
A REPORT WAS RECEIVED ON (B)(6) 2024 FROM THE CAREGIVER OF A 70-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD LEAKED FROM THE CARTRIDGE AFTER ADMINISTERING HEPARIN DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 15 NOV 2024 FROM THE HOME THERAPY NURSE (HTN), WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. THE PATIENT HAS RESUMED THERAPY WITH HIS REPLACEMENT NXSTAGE CYCLER.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20863977 ↗MalfunctionNov 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2024 FROM A 42-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THEY EXPERIENCED A CARTRIDGE BLOOD LEAK DURING A HOME HEMODIALYSIS TREATMENT ON AN UNSPECIFIED DAY. ADDITIONAL INFORMATION WAS RECEIVED ON 28 OCT FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20673007 ↗MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2024 FROM A 39-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 06 SEP 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20245424 ↗MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 21 AUG 2024 FROM THE CAREGIVER OF A 78-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ALTHOUGH REQUESTED, THERE WAS NO FURTHER INFORMATION PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20211738 ↗MalfunctionJul 16, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
A REPORT WAS RECEIVED ON 20 JUN 2024 FROM THE CAREGIVER (CG) OF A 69-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE ¿VENOUS LOCK SITE¿ DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. TREATMENT WAS TERMINATED WITHOUT RINSEBACK. THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21 JUN 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THAT THE PATIENT ATTACHED A SYRINGE TO THE PORT AND THE LEAK STOPPED. THE BLOOD LOSS WAS 'MINOR, A FEW DRIPS'. THERE WERE NO SYMPTOMS RELATED TO THE EVENT. THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19756795 ↗InjuryJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 11 JUN 2024 FROM THE HOME THERAPY NURSE (HTN) OF A 58 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE APPROXIMATELY TWENTY MINUTES INTO A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 14-19 JUN 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT PRESENTED TO HOSPITAL WITH DIZZINESS AND WAS ADMITTED ON (B)(6) 2024. ADDITIONAL INFORMATION REGARDING HOSPITALIZATION AND DISCHARGE DATE WAS NOT PROVIDED. FOLLOWING DISCHARGE, THE PATIENT PERFORMED AN UNEVENTFUL HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024.
Patient problems: Dizziness; Hemorrhage/Blood Loss/Bleeding
MAUDE report 19633212 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON (B)(6) 2024 FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A 51 YEAR OLD FEMALE PATIENT WITH DIABETES AND END STAGE RENAL DISEASE, STATING THE PATIENT EXPERIENCED SHORTNESS OF BREATH, COUGHING, WHEEZING, CHEST PAIN, HYPOTENSION (NOS), AND BODY PAIN DURING HER FIRST HEMODIALYSIS TREATMENT WITH THE DEVICE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 22 MAY 2024 FROM THE HCP WHO STATED ALL SYMPTOMS ONSET WITHIN TEN MINUTES OF INITIATING TREATMENT. OXYGEN THERAPY, TWO PUFFS OF ALBUTEROL (VENTOLIN), AND A SALINE BOLUS (200ML) WERE ADMINISTERED, AND TREATMENT WAS TERMINATED. SYMPTOMS RESOLVED FOLLOWING INTRAVENOUS DIPHENHYDRAMINE 50MG (BENADRYL). FOLLOWING THE EVENT, THE PATIENT RECOVERED WITHOUT SEQUELAE AND CHANGED TO A DIALYZER FROM A DIFFERENT MANUFACTURER.
Patient problems: Chest Pain; Cough; Dyspnea; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Wheezing
MAUDE report 19460940 ↗MalfunctionMay 2, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
A REPORT WAS RECEIVED ON 18 APR 2024 FROM A 50 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 18 APR 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED, THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19230365 ↗
Other Dialyzer, High Permeability With Or Without Sealed Dialysate System devices
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- 2008® Series Hemodialysis Machines 190713Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls37 deaths893 reports
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page