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Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis

The FDA is aware that Nuwellis has issued a letter to affected health care providers recommending certain lots of AquaFlexFlow UF 500 Plus extracorporeal blood circuits be removed from use as a result of a potentially high-risk device issue.

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 too many weight mismatch alarms occur, the Aquadex console will terminate therapy with that blood circuit. If therapy is terminated, it could cause excess fluid removal from a patient, leading to acute volume depletion, which could also be referred to as hypovolemia or dehydration, which is especially serious in pediatric patients. A new blood circuit must be primed if continued therapy is desired.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Questions?

Customers in the U.S. with questions about this recall should contact Nuwellis Customer Service at orders@nuwellis.com or 855-786-2778.