FDA Device Intelligence
Home › Nuwellis Inc. › AquaFlexFlow UF 500 Plus

AquaFlexFlow UF 500 Plus

Nuwellis Inc. · Model 114156 · UDI-DI 10853072007111

KDI Prescription
1
510(k) clearances
43,552
Adverse events (2,583 deaths)
217
Recalls
87
Facilities

Description

For use with the Aquadex System. The Aquadex 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.

Recalls

DateFirmReason
2026-06-30Fresenius Medical Care Renal Therapies Group, LLCFresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis ma
2026-05-11Fresenius Medical Care Holdings, Inc.Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2026-01-06VANTIVE US HEALTHCARE LLCThere is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2025-10-27Nipro Medical CorporationScrew may loosen or fallout of Hemodialysis system

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.