nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog… recallZ-0831-2025 · Nuwellis Inc · initiated Dec 11, 2024
Class I Completed All recalls posted in January 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nuwellis Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Nuwellis issued an UREGNT: MEDICAL DEVICE RECALL notice to its consignees on 12/11/2024 via email. The notice explained the issue, risk to health, and requested the following actions be taken: Immediately discontinue use of affected lots. A Nuwellis representative will be reaching out to arrange return or disposal of the affected product to Nuwellis. For more detailed discussion regarding this product return, you may contact the Quality Team at Nuwellis: Steve Sandoval, Director of Engineering and Quality, Email: [email protected], Office Phone: +1 952.563.7040
Recall details
- Recall number
- Z-0831-2025
- Recall class
- Class I (most serious)
- Status
- Completed
- Initiated by the company
- Dec 11, 2024
- Posted by the FDA
- Jan 16, 2025
- Recalling firm
- Nuwellis Inc
- Quantity
- 845 units
- Product code
- KDI
- FDA submissions
- K192756
- Distribution
- US Nationwide Distribution and the country of Hong Kong
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
Code information (models, lots, serial 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.
Other devices under the same FDA submission
1 device cleared under K192756 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Aquadex SmartFlow Console 120100Nuwellis Inc. · Dialyzer, High Permeability With Or Without Sealed Dialysate System3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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