NXSTAGE CARTRIDGE CAR-124-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M535CAR124C0), received between Aug 31, 2022 and Aug 12, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 4 most recent of 4 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 20 Jul 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. 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 50220215 ↗
• InjuryJan 6, 2026Improper or Incorrect Procedure or Method

  A REPORT WAS RECEIVED ON 11 DEC 2025 FROM A HEALTH CARE PROFESSIONAL (HCP), REGARDING A 38 YEAR OLD FEMALE PATIENT, STATING THE PATIENT EXPERIENCED ACUTE INTRAVASCULAR HEMOLYSIS AND WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES (EMS) TO HOSPITAL, DATE UNSPECIFIED. ADDITIONAL INFORMATION WAS RECEIVED ON 19 DEC 2025 FROM THE HCP WHO STATED THE PATIENT WAS HOSPITALIZED FOR 72 HOURS AND WAS DISCHARGED TO RESUME THERAPY WITH A DIFFERENT CARTRIDGE.

  Patient problems: Hemolysis

  MAUDE report 23975939 ↗
• MalfunctionMar 13, 2025Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2025 FROM A HEALTHCARE PROFESSIONAL, REGARDING A FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM "A CRACK" DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 21593289 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2022 FROM THE NURSE OF A 16 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING NEPHRONOPHTHISIS AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT SHOWED SIGNS OF HEMOLYSIS (NOS) AND EXPERIENCED BACK PAIN APPROXIMATELY TWO HOURS INTO AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2022. PER THE NURSE, THE PATIENT "APPEARS TO BE FINE" BUT WILL BE KEPT AT THE HOSPITAL OVERNIGHT TO BE OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED ON 23 AND 25 AUG 2022 FROM THE NURSE WHO CONFIRMED THE PATIENT WAS OBSERVED OVERNIGHT, AND EXPERIENCED ADDITIONAL SYMPTOMS OF INCREASED POTASSIUM 6 MEQ/L, INCREASED BLOOD PRESSURE (NOS) AND VOMITING, ALL RESOLVED WITHOUT MEDICAL INTERVENTION. PER THE NURSE, PATIENT WAS RELEASED ON THE EVENING OF (B)(6) 2022 AND WILL RESUME THERAPY WITH NXSTAGE.

  Patient problems: Hemolysis; High Blood Pressure/ Hypertension; Hyperkalemia; Pain; Vomiting

  MAUDE report 15326565 ↗