Nuwellis Inc is recalling 845 units of the AquaFlexFlow UF 500 Plus extracorporeal blood circuit. This component, used with Aquadex SmartFlow and FlexFlow systems, may trigger "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" alarms during use. While no injuries have been reported, this defect can lead to incorrect fluid removal from patients. Consumers should contact the manufacturer or their medical distributor to arrange for a return or replacement of affected units.
The device failure can result in excessive fluid removal from a patient, leading to acute volume depletion. This condition is especially dangerous for pediatric patients who are more vulnerable to rapid changes in blood volume.
Manufacturer correction or return
Used with Aquadex SmartFlow or Aquadex FlexFlow System; Recall #: Z-0831-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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