FDA Medical devices recall ·
nuwellis AquaFlexFlow UF 500 Plus recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0831-2025
- Date
- (initiated December 11, 2024)
- Company / brand
- Nuwellis Inc
12988 Valley View Rd, Eden Prairie, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Completed
- Units affected
- 845 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
US Nationwide Distribution and the country of Hong Kong
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0831-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.