Z-0831-2025Class I

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is...

Name: Z-0831-2025 nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is...
Creator: Nuwellis Inc
Published: 2024-12-11
License: https://open.fda.gov/license/

Nuwellis, Inc. / initiated 2024-12-11 / Completed

FDA source

Nuwellis Inc began a recall of nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow... on 2024-12-11. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0831-2025
Classification: Class I
Status: Completed
Initiated: 2024-12-11
Posted: 2025-01-16
Recalling firm: Nuwellis, Inc.
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 845 units
Distribution: US Nationwide Distribution and the country of Hong Kong
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0831-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0831-2025	Class I	Completed	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code KDI

K192756Class IIAquadex FlexFlow System 2.0Chf Solutions, Inc. / cleared 2020-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)