Nuwellis Inc recalls nuwellis AquaFlexFlow UF 500 Plus

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.

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: Steve.Sandoval@nuwellis.com, Office Phone: +1 952.563.7040

• FDA enforcement recordOfficial FDA database entry for Z-0831-2025
• FDA 510(k) clearance · K192756The device's official FDA premarket clearance record
• FDA device classification · KDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nuwellis IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.