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Nuwellis Inc recalls nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th
Recalled January 22, 2025 · FDA recall Z-0831-2025 · Nuwellis
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. · FDA Class I
Units
845 units
Sold at
US Nationwide Distribution and the country of Hong Kong
Description
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.
Product
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Manufacturer(s)
Nuwellis Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →