NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP CAR-535Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M535CAR5350), received between Nov 30, 2023 and Jan 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 15 DEC 2023 FROM THE NURSE OF A 50 YEAR OLD MALE CRITICAL CARE PATIENT, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 20 DEC 2023 FROM THE NURSE WHO STATED THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE CARTRIDGE WAS REPLACED AND THE PATIENT RESUMED THERAPY WITH THE NXSTAGE SYSTEM LATER THAT DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18442800 ↗
• MalfunctionNov 30, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 13 NOV 2023 FROM THE HEALTH CARE PROFESSIONAL (HCP) OF A 29-YEAR-OLD MALE CRITICAL CARE PATIENT, WHO STATED THAT A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 16 NOV 2023 FROM THE HCP STATING THAT THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION REQUIRED. THE PATIENT CONTINUED TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18236678 ↗
• MalfunctionNov 30, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 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) THERAPY ON (B)(6) 2023. ALTHOUGH REQUESTED ADDITIONAL INFORMATION WAS NOT PROVIDED, THERE IS NO INDICATION THE PATIENT EXPERIENCED ANY SYMPTOMS RELATED TO THE EVENT AND THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18236647 ↗