Aquadex SmartFlow Console 120100Recalls & reported problems
Nuwellis Inc. · The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. · Class 2
- 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 10853072007104), received between Jan 27, 2026 and Mar 30, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Inaccurate Flow Rate” (1 report).
1 other recall cover devices cleared under the same FDA submission (K192756); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Inaccurate Flow Rate1
Patient problems
- Convulsion/Seizure1
- Dehydration1
- Hypovolemia1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTS DEVICE FLUID REMOVAL WAS APPROXIMATELY 20 ML/HR HIGH DURING DAYSHIFT, AND APPROXIMATELY 40 ML/HR HIGH DURING NIGHT SHFIT. CUSTOMER BELIEVES THIS MAY HAVE CONTRIBUTED TO THE PATIENT BECOMING HYPOTENSIVE AND REQUIRING FLUID ADMINISTRATION.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 24714089 ↗InjuryFeb 27, 2026Inaccurate Flow Rate
THE PATIENT WAS ON THERAPY AND DURING THE NIGHT, THE NURSES GOT SEVERAL WEIGHT SCALE MISMATCH ALARMS. USER ESTIMATED THE PATIENT LOST 300MLS IN 30 MINS.
Patient problems: Convulsion/Seizure; Hypovolemia
MAUDE report 24471749 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTS "DEVICE PULLED 350MLS MORE OVER 2 HOURS REQUIRING THE NEED FOR VASOACTIVE SUPPORT AND FLUID BOLUSES." CUSTOMER DID NOT REPORT OR ALLEGE THAT ANY PATIENT HARM OCCURRED AS A DIRECT OR INDIRECT RESULT OF THE REPORTED EVENT.
Patient problems: Dehydration
MAUDE report 24190012 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K192756. One submission often covers many models, so check the product and lot details in each record.
- Z-0831-2025 · Dec 11, 2024 · Completednuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Other Dialyzer, High Permeability With Or Without Sealed Dialysate System devices
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- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.