Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
nuwellis AquaFlexFlow UF 500 Plus Recalled by Nuwellis Inc Due to The AquaFlexFlow UF 500 Plus extracorporeal blood circuit...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nuwellis Inc directly.
Affected Products
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Quantity: 845 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nuwellis Inc
Nuwellis Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report