CWP RO,CWP,28LPM,104HRecalls & reported problems
Mar Cor Purification, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817492020733), received between Mar 28, 2018 and Mar 28, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Fitting Problem” (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 16, 2026.
Most reported problems
Device problems
- Fitting Problem2
Patient problems
- Abrasion1
- Nerve Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2018Fitting Problem; Fitting Problem
A FACILITY REPORTED WHILE A PATIENT CARE TECHNICIAN WAS DISCONNECTING THE ACID CONNECTIONS FROM THE DIALYSIS WALL BOX USED WITH THEIR CWP 100 CENTRAL WATER TREATMENT SYSTEM, THE TECHNICIAN CUT HER HAND ON THE DIALYSIS CHAIR AFTER THE CONNECTOR FITTING RELEASED.
Patient problems: Abrasion
MAUDE report 7380115 ↗InjuryMar 28, 2018Fitting Problem; Fitting Problem
A FACILITY REPORTED WHILE A PATIENT CARE TECHNICIAN WAS DISCONNECTING THE ACID CONNECTIONS FROM THE DIALYSIS WALL BOX USED WITH THEIR CWP 100 CENTRAL WATER TREATMENT SYSTEM, THE TECHNICIAN HIT HIS HAND ON THE BASE OF THE WALL BOX, CAUSING NERVE DAMAGE IN HIS HAND. THE TECHNICIAN WAS REPORTED TO BE OUT OF WORK FOR ONE WEEK AS A RESULT OF THE REPORTED HAND INJURY.
Patient problems: Nerve Damage
MAUDE report 7380079 ↗
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- AquaBplus & AquaBplus B2 & AquaBplus HF 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
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- Ultrafilter U 9000 112062Gambro Dialysatoren GmbH · Subsystem, water purification6 reports
- Millenium HX RO,MILLENIUM HX,750GPD,115~,60HZMar Cor Purification, Inc. · Subsystem, Water Purification3 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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