AquaBplus & AquaBplus B2 & AquaBplus HF 2500Recalls & reported problems
VIVONIC GmbH · The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. These devices are intended to be a component in a complete water purification system, and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 3, 2021Class IITerminated
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation
Z-1364-2022 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Other Subsystem, Water Purification devices
- Tablo(R) Hemodialysis System PN-0003000Outset Medical, Inc. · Subsystem, Water Purification3 recalls34 deaths83 reports
- AquaC UNO HVIVONIC GmbH · Subsystem, Water Purification4 recalls0 reports
- TabloCart™ with Prefiltration Drawer PN-0006813Outset Medical, Inc. · 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
- 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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