nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with th
Summary
The FDA issued a Class I for nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorpo by Nuwellis Inc. Reason: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mism.
Details
Source
Device Recall
External ID
Z-0831-2025
Action Date
2025-01-22
Status
Completed
Category
device
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
Lot/Code Info: 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 Affected: 845 units
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.
Distribution
US Nationwide Distribution and the country of Hong Kong
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-11
Company
Eden Prairie, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nuwellis Inc has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nuwellis Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nuwellis Inc have FDA actions?
Nuwellis Inc has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0831-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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