Nuwellis recalls AquaFlexFlow UF 500 Plus blood circuits with specific lot numbers due to potential excess fluid removal causing acute volume depletion, especially in pediatric patients.
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 is recalling certain AquaFlexFlow UF 500 Plus blood circuits used with Aquadex systems. If not fixed, these circuits could remove too much fluid from patients, leading to dangerous low blood volume, particularly in children.
The circuit may trigger alarms indicating excessive fluid removal. If unaddressed, this can cause acute volume depletion in patients, which is especially dangerous for children.
Patients using the AquaFlexFlow UF 500 Plus circuit with Aquadex SmartFlow or FlexFlow systems are affected. Children are at higher risk due to the potential for acute volume depletion.
Check for lot numbers 22697 through 22740 on the AquaFlexFlow UF 500 Plus circuit. This product is used with Aquadex SmartFlow or FlexFlow systems.
Look for "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" alarms during use.
Reach out to Nuwellis for guidance on addressing the issue if alarms occur.
The product may indicate alarms that could lead to excess fluid removal, so it's not safe to use without addressing the issue.
Check for lot numbers 22697 through 22740 on the AquaFlexFlow UF 500 Plus circuit used with Aquadex SmartFlow or FlexFlow systems.
Contact Nuwellis for guidance on addressing the issue if alarms occur.
We’ve drafted a message you can send Nuwellis to request your refund or repair — edit it as you like.
Subject: Recall Z-0831-2025 — Nuwellis Nuwellis Hello, I own a Nuwellis that is covered by recall Z-0831-2025 from Nuwellis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
