Nuwellis Inc medical device recall: nuwellis AquaFlexFlow UF 500 Plus
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Completed
- Event ID
- 95991
- Recall initiated
- Dec 11, 2024
- Classified by FDA
- Jan 16, 2025
- Posted in Enforcement Report
- Jan 22, 2025
- Recalling firm
- Nuwellis Inc
- Firm location
- Eden Prairie, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 11, 2024. FDA classified it 36 days later, on Jan 16, 2025. Distribution reported by FDA: US Nationwide Distribution and the country of Hong Kong
Recalled products (1)
Z-0831-2025 Class I Completed
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
Codes / lots: 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.
Quantity: 845 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95991
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.