Nuwellis Inc: Device Recall
Recall #Z-0831-2025 · 12/11/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-0831-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Nuwellis Inc
- Status
- Completed
- Date Initiated
- 12/11/2024
- Location
- Eden Prairie, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 845 units
Reason for Recall
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 Description
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Distribution Pattern
US Nationwide Distribution and the country of Hong Kong
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.