NXSTAGE CARTRIDGE EXPRESSRecalls & reported problems across all models

We found 4 models of NXSTAGE CARTRIDGE EXPRESS by Nxstage Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2018 and Aug 12, 2026 — classified as 1 death, 98 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (90 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 NXSTAGE CARTRIDGE EXPRESS problems

NXSTAGE CARTRIDGE EXPRESS models

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

• NXSTAGE CARTRIDGE EXPRESS CAR-172-C

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  101 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-170-C

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  57 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-500

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 death26 reports
• NXSTAGE CARTRIDGE EXPRESS CAR-505

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  22 reports

Recent NXSTAGE CARTRIDGE EXPRESS adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 23, 2026

  RN STARTED SETTING UP CRRT. HOWEVER, THE MACHINE WAS CONTINUOUSLY ALARMING ALERT 85- CHECK CARTRIDGE WASTE LINE FAILURE. AFTER FOLLOWING THE PROCEDURE TO FIX THIS ISSUE, THE MACHINE CONTINUED TO ALARM. AFTER 3 ATTEMPTS, THE MACHINE CONTINUED TO ALARM. THE RN THEN SWITCHED OUT THE CARTRIDGE 3 TIMES. THE SAME ALARM SEQUENCE OCCURRED. IT WAS THEN DETERMINED THAT WE WERE DEALING WITH A DEFECTIVE BATCH OF CRRT CARTRIDGES, AND ALL WERE FROM THE SAME LOT NUMBER. THIS CAUSED A DELAY IN THE PATIENT RECEIVING LIFE-SAVING CRRT. MANUFACTURER RESPONSE FOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM, NXSTAGE CARTRIDGE EXPRESS (PER SITE REPORTER). UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592465 ↗
• 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 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(4) 2026 FROM THE HOME THERAPY NURSE (HTN) OF A 75 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HIVES, ITCHING, AND DIFFICULTY BREATHING APPROXIMATELY TEN MINUTES INTO A HEMODIALYSIS TREATMENT ON (B)(4) 2026. TREATMENT WAS TERMINATED WITH RINSEBACK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOME THERAPY MANAGER (HTM) WHO STATED SYMPTOMS RESOLVED APPROXIMATELY TEN MINUTES AFTER ADMINISTERING OXYGEN, 125MG INTRAVENOUS METHYLPREDNISOLONE (SOLU-MEDROL), AND 50MG ORAL DIPHENHYDRAMINE (BENADRYL). PER THE HTM, THE PATIENT RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

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

  MAUDE report 24558321 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 04 MAR 2026 FROM THE HOME THERAPY NURSE (HTN) OF A 75 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HIVES, ITCHINESS AND DIFFICULTY BREATHING DURING A IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 06 MAR 2026 FROM THE HTN WHO STATED THE PATIENT WAS ADMINISTERED OXYGEN, METHYLPREDNISOLONE (SOLU-MEDROL) 125MG, AND DIPHENHYDRAMINE (BENADRYL) 50MG INTRAVENOUSLY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND DISCHARGED. FOLLOWING THE EVENT, THE PATIENT RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

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

  MAUDE report 24557754 ↗
• 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 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 22 AUG 2025 FROM THE NURSE OF A 62-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT'S BLOOD PRESSURE DROPPED (68/48 MMHG) AND HE EXPERIENCED ITCHING WITHIN THE FIRST FIVE MINUTES OF AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 25 AUG 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT WAS ALSO LETHARGIC AND SWEATING. TREATMENT WAS TERMINATED AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED, 50MG INTRAVENOUS DIPHENHYDRAMINE (BENADRYL), A SALINE BOLUS AND ORAL GLUCOSE WERE ADMINISTERED TO THE PATIENT. EMS ARRIVED ON SCENE, OXYGEN WAS GIVEN TO THE PATIENT, HE WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. PER THE HTN, THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2025 AND HAS RESUMED THERAPY WITH THE NXSTAGE SYSTEM.

  Patient problems: Diaphoresis; Hypersensitivity/Allergic reaction; Lethargy; Low Blood Pressure/ Hypotension

  MAUDE report 22903737 ↗
• 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 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2025 FROM THE NURSE OF A 56-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT WAS ITCHY APPROXIMATELY ONE HOUR INTO A HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 FROM THE NURSE WHO STATED THE PATIENT ALSO EXPERIENCED HIVES AND WAS ADMINISTERED 50MG INTRAVENOUS DIPHENHYDRAMINE (BENADRYL). PER THE NURSE, THE PATIENT CONTINUES TO TREAT WITH NXSTAGE.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Urticaria

  MAUDE report 21872242 ↗

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