Official recall record

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow

US FDA — Medical Devices · 2024-12-11 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Alert date: 2024-12-11
Country of alert: United States
Alert level: Class I
Alert type: recall
Brand on record: Nuwellis Inc

What the authority reported

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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