Skip to content

NxStage PureFlow B Solution RFP-404Recalls & reported problems

Nxstage Medical, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M535RFP4040), received between Apr 3, 2018 and Apr 3, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 3, 2018Break

    TWO HEMODIALYSIS BAGS POPPED DURING ACTIVATION COULD NOT BE USED FOR DIALYSIS. NEW BAGS WERE OBTAINED FROM PHARMACY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7391748 ↗

Other Dialysate Concentrate For Hemodialysis (Liquid Or Powder) devices

All Dialysate Concentrate For Hemodialysis (Liquid Or Powder) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.