NXSTAGE CARTRIDGE CAR-125-BRecalls & reported problems
Nxstage Medical, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M535CAR125B0), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Anemia1
- Asthma1
- High Blood Pressure/ Hypertension1
- Seizures1
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED ON 8 OCT 2019 FROM THE HOME THERAPY NURSE (HTN), REGARDING AN (B)(6) MALE WITH MULTIPLE COMORBIDITIES INCLUDING ASTHMA, INFERIOR VENA CAVA THROMBOSIS, CLOTTING DISORDER, ANEMIA, HYPERTENSION, SEIZURES, POLYCYSTIC KIDNEY AND TRANSPLANT FAILURE WHO HAD PINK-TINGED EFFLUENT THAT TESTED NEGATIVE FOR BLOOD DURING STANDARD HOME HEMODIALYSIS THERAPY ON (B)(6) 2019. PER THE HTN TREATMENT WAS TERMINATED AND THE PATIENT WAS TAKEN TO HOSPITAL BY THE CAREGIVER FOR PRECAUTIONARY OBSERVATION. ADDITIONAL INFORMATION WAS RECEIVED 08 OCT 2019 - 30 OCT 2019 FROM THE HTN WHICH REVEALED THE PATIENT WAS ADMITTED TO HOSPITAL FROM (B)(6) 2019 FOR BLOOD TESTS AND CULTURES (NOS) WHICH WERE UNREMARKABLE. THE PATIENT DID NOT EXPERIENCE SYMPTOMS AND RECEIVED DIALYSIS WHILE HOSPITALIZED WITH NO ADDITIONAL EVENTS REPORTED.
Patient problems: Anemia; Asthma; High Blood Pressure/ Hypertension; Seizures; Thrombosis
MAUDE report 9268126 ↗
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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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