Nephros SSU-D UltraFilter 70-0243DRecalls & reported problems
Nephros, Inc. · The Nephros SSU-D UltraFilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. It assists in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore it must be used in conjunction with other water treatment equipment (RO, DI, etc.). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00896241002220), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Filtration Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Filtration Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2026Filtration Problem; Material Deformation
ON (B)(6) 2026 IT WAS REPORTED THAT A HEALTHCARE FACILITY RECEIVED A POSITIVE ENDOTOXIN CULTURE DOWNSTREAM OF AN SSU-D (70-0243D) FILTER ON ONE OF THEIR RO MACHINES AND OBSERVED THE DEVICE HAD DEFORMED. THERE WAS NO REPORTED ADVERSE EVENT. THE NEPHROS SSU-D IS INTENDED TO BE USED TO FILTER WATER OR BICARBONATE CONCENTRATE USED IN HEMODIALYSIS DEVICES. IT ASSISTS IN PROVIDING HEMODIALYSIS QUALITY WATER OR BICARBONATE CONCENTRATE. THE DEVICE IS NOT A COMPLETE WATER TREATMENT SYSTEM BUT SERVES TO REMOVE BIOLOGICAL CONTAMINANTS. THEREFORE, IT MUST BE USED IN CONJUNCTION WITH OTHER WATER TREATMENT EQUIPMENT (RO, DI, ETC.). THE USER FACILITY ROUTINELY TESTS THEIR WATER TO ENSURE THE REMOVAL OF ENDOTOXINS. A POSITIVE ENDOTOXIN CULTURE CAN BE CAUSED BY IMPROPER INSTALLATION, CROSS CONTAMINATION AND/OR A BREACH OF THE FILTER MEMBRANE. COMPREHENSIVE REVIEW OF THE SPECIFIC FILTER DEVICE HISTORY RECORD AND MANUFACTURING INSPECTIONS DID NOT IDENTIFY ANY PRODUCT ISSUES AND THE INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL/FOLLOWUP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781038 ↗
Other Subsystem, Water Purification devices
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- 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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