NXSTAGE CARTRIDGE EXPRESS CAR-505Recalls & 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
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI M535CAR5050), received between Oct 24, 2018 and Jun 23, 2026 — classified as 5 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 Leak12
- Break8
- No Apparent Adverse Event3
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Entrapment of Device1
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- Hemorrhage/Blood Loss/Bleeding8
- No Clinical Signs, Symptoms or Conditions8
- Foreign Body In Patient3
- Anemia2
- No Known Impact Or Consequence To Patient2
- Tachycardia2
- Anxiety1
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2025 FROM THE CRITICAL CARE NURSE OF A PATIENT OF UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6)2025. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21528485 ↗MalfunctionJan 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 03 JAN 2025 FROM THE HEALTH CARE PROFESSIONAL (HCP) OF A 51-YEAR-OLD CRITICAL CARE PATIENT, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON 03 JAN 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 03 JAN 2025 FROM THE HCP WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21230330 ↗InjuryAug 28, 2024Fluid/Blood Leak; Use of Device Problem; Fluid/Blood Leak; Use of Device Problem
A REPORT WAS RECEIVED ON 06 AUG 2024 FROM A NURSE REGARDING A 68 YEAR OLD MALE CRITICAL CARE PATIENT WITH COMORBIDITIES INCLUDING CHOLANGIOCARCINOMA AND HYPERTENSION, WHO STATED THE PATIENT BECAME SYMPTOMATIC WHEN APPROXIMATELY 500ML BLOOD LEAKED FROM THE CARTRIDGE BLOODLINE DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2024. THE PATIENT¿S VASOPRESSOR THERAPY WAS TITRATED (NOREPINEPHRINE BITARTRATE/LEVOPHED AND PHENYLEPHRINE) AND 1L OF LACTATED RINGERS WAS ADMINISTERED TO ADDRESS THE ACUTE EVENT, FOLLOWED BY ONE UNIT OF PACKED RED BLOOD CELLS FLUIDS. ADDITIONAL INFORMATION WAS RECEIVED ON 12 AUG 2024 FROM THE NURSE WHO STATED THE PATIENT EXPERIENCED HYPOTENSION, TACHYCARDIA, AND ANEMIA. PER THE NURSE, THE PATIENT CONTINUED TO RECEIVE THERAPY WITH THE NXSTAGE SYSTEM.
Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Tachycardia
MAUDE report 20089181 ↗MalfunctionOct 26, 2023Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event
A REPORT WAS RECEIVED ON 05 OCT 2023 FROM THE HEALTH PROFESSIONAL OF A CRITICAL CARE PATIENT OF UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE LUER CONNECTOR BROKE AND BLOOD COULD NOT BE RETURNED TO THE PATIENT DURING A CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 06 OCT 2023 FROM THE HEALTH PROFESSIONAL WHO STATED THERE WAS NO REPORT OF ADVERSE IMPACT TO THE PATIENT OR REPORT OF MEDICAL INTERVENTION BEING REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18014341 ↗MalfunctionAug 31, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 24 AUG 2023 FROM THE NURSE WHO STATED, RINSEBACK WAS UNABLE TO BE PERFORMED, NO REPORT OF SYMPTOMS EXPERIENCED OR OF MEDICAL INTERVENTION BEING REQUIRED, PATIENT WILL RESUME CRRT WITH NXSTAGE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17662729 ↗InjuryMay 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE HEALTH PROFESSIONAL (HP) OF A MALE CRITICAL CARE PATIENT WITH MULTIPLE COMORBIDITIES INCLUDING ANEMIA, WHO STATED THE CARTRIDGE WAS LEAKING DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HP STATING THAT THE PATIENT RECEIVED ONE UNIT OF PACKED RED BLOOD CELLS AND RESUMED CRRT WITH A NEW CARTRIDGE.
Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding
MAUDE report 16942703 ↗MalfunctionApr 6, 2023Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE CLINICAL NURSE MANAGER (NM) AT A CRITICAL CARE FACILITY REGARDING A PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE LUER CONNECTOR BROKE WHEN ATTEMPTING RINSEBACK OF A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND BLOOD COULD NOT BE RETURNED TO THE PATIENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE NM STATING THAT THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION REQUIRED AND THAT PATIENT CONTINUED THERAPY WITH THE NXSTAGE SYSTEM USING A NEW CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16688731 ↗MalfunctionFeb 10, 2023Break; Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE NURSE OF A 58-YEAR-OLD CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE DIALYSIS TUBING BROKE AND THE PATIENT SUSTAINED A BLOOD LOSS DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2023. PER THE NURSE, NORMAL SALINE WAS RUNNING CONCURRENTLY AT 500ML/HOUR THROUGH THE DIALYSIS CIRCUIT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE INTENSIVE CARE UNIT NURSE MANAGER (NM) STATING THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE ADDITIONAL MEDICAL INTERVENTION AND RESUMED CRRT WITH A NEW DIALYSIS CIRCUIT USING THE NXSTAGE SYSTEM.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 16352025 ↗MalfunctionFeb 2, 2023Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE CRITICAL CARE NURSE OF A PATIENT OF UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE NURSE WHO STATED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE IMPACT DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16284645 ↗MalfunctionFeb 2, 2023Break; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 18 JAN 2023 FROM THE NURSE AT A CRITICAL CARE FACILITY REGARDING A PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE LUER CONNECTOR BROKE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT AND BLOOD COULD NOT BE RETURNED TO THE PATIENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JAN 2023 FROM THE NURSE WHO STATED THERE WAS NO ADVERSE IMPACT RELATED TO THE EVENT AND NO MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16282961 ↗MalfunctionDec 8, 2022Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2022 FROM THE CRITICAL CARE NURSE (CCN) OF A PATIENT OF UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 29 NOV 2022 FROM THE CCN 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 15944104 ↗MalfunctionDec 1, 2022Break; Fluid/Blood Leak
A REPORT WAS RECEIVED ON 04 NOV 2022 FROM A NURSE REGARDING A 74 YEAR OLD MALE CRITICAL CARE PATIENT, WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED A BLOOD LOSS THROUGH A BROKEN CONNECTION DURING A CONTINUOUS RENAL REPLACEMENT THERAPY ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 09 NOV 2022 FROM THE NURSE WHO STATED THE CONNECTION BROKE ON THE VENOUS ACCESS LINE. TREATMENT WAS TERMINATED WITHOUT RINSEBACK AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION RELATED TO THE EVENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15897489 ↗MalfunctionOct 29, 2022Fluid/Blood Leak
A REPORT WAS RECEIVED ON 20 OCT 2022 FROM THE CRITICAL CARE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED A BLOOD LEAK OCCURRED DURING A CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION WAS RECEIVED ON 21 OCT 2022 FROM THE CRITICAL CARE NURSE STATING THERE WERE NO SYMPTOMS, MEDICAL INTERVENTION OR PROLONGATION OF HOSPITALIZATION. ALTHOUGH REQUESTED, ADDITIONAL DETAIL WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15696379 ↗MalfunctionOct 28, 2022Fluid/Blood Leak
A REPORT WAS RECEIVED ON (B)(6) 2022 FROM THE CRITICAL CARE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED A BLOOD LEAK OCCURRED DURING A CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION WAS RECEIVED ON 21 OCT 2022 FROM THE CRITICAL CARE NURSE STATING THERE WERE NO SYMPTOMS, MEDICAL INTERVENTION OR PROLONGATION OF HOSPITALIZATION. ALTHOUGH REQUESTED, ADDITIONAL DETAIL WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15691673 ↗MalfunctionSep 2, 2022Loose or Intermittent Connection
A REPORT WAS RECEIVED ON 11 AUG 2022 FROM THE CRITICAL CARE STAFF NURSE OF A PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE VENOUS CONNECTOR CAME LOOSE AT THE BEGINNING OF A HEMODIALYSIS TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 FROM THE NURSE WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15347540 ↗MalfunctionSep 30, 2020Break
A REPORT WAS RECEIVED ON (B)(6) 2020 FROM THE CLINICAL NURSE SPECIALIST OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY STATING THE CARTRIDGE VENOUS LINE LUER BROKE WITHIN THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC) DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION ON (B)(6) 2020. THE PATIENT''S CVC REQUIRED REPLACEMENT.
Patient problems: Foreign Body In Patient
MAUDE report 10607753 ↗InjuryAug 21, 2020Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 30 JUL 2020 FROM THE PHYSICIAN OF A (B)(6) YEAR OLD MALE IN CRITICAL CARE FOR TREATMENT OF PERICARDIAL EFFUSION AND FLUID OVERLOAD, WITH MULTIPLE COMORBIDITIES INCLUDING KNOWN DIALYZER REACTIONS DURING DIALYSIS THERAPY, WHO EXPERIENCED SYMPTOMS 10 ¿ 15 MINUTES INTO CONTINUOUS RENAL REPLACEMENT THERAPY ON (B)(6) 2020. SYMPTOMS INCLUDED CHANGE OF TASTE, TACHYPNEA, LABILE PULSE, HYPOXIA, HYPERTENSION, AND ANXIETY. ADDITIONAL INFORMATION WAS RECEIVED ON 5 AUG 202 FROM THE PHYSICIAN STATING THE PATIENT¿S OXYGEN LEVEL DROPPED FROM ~90% TO 67%, SYSTOLIC BLOOD PRESSURE INCREASED FROM 100MMHG TO 144MMHG, HEART RATE INCREASED FROM 110BPM TO 140BPM AND RESPIRATORY RATE INCREASED FROM ~30 TO 40/M. 25MG BENADRYL WAS ADMINISTERED INTRAVENOUSLY TO ADDRESS THE SYMPTOMS.
Patient problems: Anxiety; High Blood Pressure/ Hypertension; Hypoxia; Increased Respiratory Rate; No Code Available; Tachycardia
MAUDE report 10439148 ↗MalfunctionMar 3, 2020Break; Entrapment of Device
A REPORT WAS RECEIVED ON 14 FEB 2020 FROM THE NURSE OF A (B)(6) YEAR OLD FEMALE PATIENT IN CRITICAL CARE FOR UNSPECIFIED PATHOLOGY, STATING THE CARTRIDGE ARTERIAL LUER BROKE WITHIN THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC) DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2020. ADDITIONAL INFORMATION WAS RECEIVED ON 20 FEB 2020 FROM THE FACILITY'S CHARGE NURSE (CN) STATING A PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE OF LUER FROM THE PATIENT'S CVC. NO REPAIR OR REPLACEMENT WAS REQUIRED AND NO SYMPTOMS WERE EXPERIENCED. THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM USING THEIR CATHETER FOR VASCULAR ACCESS.
Patient problems: Foreign Body In Patient
MAUDE report 9781789 ↗MalfunctionNov 14, 2018Break
A REPORT WAS RECEIVED ON (B)(6) 2018 FROM A NURSE REGARDING A CARTRIDGE LUER THAT BROKE WHEN DISCONNECTING A PATIENT FROM CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) THERAPY ON (B)(6) 2018. THERE WAS NO REPORTED ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8068799 ↗InjuryNov 8, 2018Break; Detachment of Device or Device Component
A REPORT WAS RECEIVED ON (B)(6) 2018 FROM A NURSE WHO REPORTED THAT THE ARTERIAL LINE BROKE OFF INSIDE THE PATIENT'S CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 8050914 ↗InjuryOct 24, 2018Break
A REPORT WAS RECEIVED ON (B)(6) 2018 FROM A NURSE REGARDING A CARTRIDGE LUER THAT BROKE AND WAS RETAINED IN THE CENTRAL VENOUS CATHETER OF A CRITICAL CARE PATIENT WHO WAS UNDERGOING DIALYSIS TREATMENT (NOS). THE CATHETER WAS REPLACED AND THE PATIENT RECOVERED WITHOUT SEQUELAE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7999557 ↗
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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.
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