FDA-Device2025-01-22Class I
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Nuwellis Inc
Hazard
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.
Sold states
US Nationwide Distribution and the country of Hong Kong
Affected count
845 units
Manufactured in
12988 Valley View Rd, Eden Prairie, MN, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2025Don't want to check this manually?
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