Millenium HX RO,MILLENIUM HX,750GPD,115~,60HZRecalls & reported problems
Mar Cor Purification, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817492020771), received between Feb 15, 2019 and Mar 15, 2019 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Disintegration” (2 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
Device problems
- Material Disintegration2
- Material Integrity Problem2
- Device Handling Problem1
- Inadequate Filtration Process1
- Misassembly During Maintenance/Repair1
Patient problems
- No Known Impact Or Consequence To Patient2
- Anemia1
- Hemolysis1
- Hemolytic Anemia1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2019Inadequate Filtration Process; Device Handling Problem; Misassembly During Maintenance/Repair; Inadequate Filtration Process; Device Handling Problem; Misassembly During Maintenance/Repair
A PATIENT'S DIALYSIS CLINIC REPORTED THE PATIENT WAS HOSPITALIZED AND EVALUATED FOR POSSIBLE HEMOLYSIS AND CHLORINE EXPOSURE AFTER RECEIVING HOME DIALYSIS TREATMENT IN WHICH A MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM WAS IN USE.
Patient problems: Anemia; Hemolysis; Hemolytic Anemia
MAUDE report 8426090 ↗InjuryFeb 15, 2019Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE FACILITY REPORTED OBSERVING A BROWN SUBSTANCE ON THE REVERSE OSMOSIS (RO) MEMBRANE IN THEIR MILLENIUM HX PORTABLE RO SYSTEM. THERE IS POTENTIAL FOR PATIENT OR USER EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8345765 ↗InjuryFeb 15, 2019Material Disintegration; Material Integrity Problem; Material Disintegration; Material Integrity Problem
THE FACILITY REPORTED OBSERVING A BROWN SUBSTANCE ON THE REVERSE OSMOSIS (RO) MEMBRANE IN THEIR MILLENIUM HX PORTABLE RO SYSTEM. THERE IS POTENTIAL FOR PATIENT OR USER EXPOSURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8345659 ↗
Other Subsystem, Water Purification devices
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- AquaC UNO HVIVONIC GmbH · Subsystem, Water Purification4 recalls0 reports
- TabloCart™ with Prefiltration Drawer PN-0006813Outset Medical, Inc. · Subsystem, Water Purification1 recall0 reports
- AquaBplus & AquaBplus B2 & AquaBplus HF 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaA AquaA 900HVIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaBplus AquaBplus B2 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- Ultrafilter U 9000 112062Gambro Dialysatoren GmbH · Subsystem, water purification6 reports
- CWP RO,CWP,28LPM,104HMar Cor Purification, Inc. · Subsystem, Water Purification2 reports
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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