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Nuwellis Inc
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Nuwellis Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass Inuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
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.
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