FDA Device recall Z-0831-2025
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow…
- FDA Device
- Class I
- completed
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class I recall of nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow… by Nuwellis, citing the AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mis….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0831-2025 |
| Classification | Class I |
| Status | completed |
| Initiated | 2024-12-11 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nuwellis |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | Lot Numbers: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723,…Lot Numbers: 22697, 22698, 22699, 22700, 22701, 22702, 22703, 22704, 22705, 22706, 22707, 22708, 22721, 22722, 22723, 22724, 22733, 22734, 22735, 22736, 22737, 22738, 22739, 22740. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0831-2025%22
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