Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

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 related to a potentially high-risk device issue:

• AquaFlexFlow UF 500 Plus Extracorporeal Blood Circuit
• Catalog #: A06163
• Model #: 114156
• UDI: 10853072007111
• Affected Lot Numbers:

What to Do

• On December 11, 2024, Nuwellis sent all affected customers an Urgent: Medical Device Recall recommending the following actions:
  • Immediately discontinue use of these affected lots to minimize risk of injury.
  • Review the lot number on the device labeling to preemptively visually identify affected product. The image below is an example AquaFlexFlow UF 500 Plus Label. In this example, the lot number is circled in red to highlight where to find this information on the product labeling. 
  • Do not ignore or override any console alarms.
• Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. 

Reason for Early Alert

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.

Nuwellis has reported 3 injuries associated with this issue.

Device Use

The AquaFlexFlow UF 500 Plus is a single use blood circuit set indicated for use with the Aquadex SmartFlow Systems. The Aquadex SmartFlow System is indicated for continuous ultrafiltration therapy for use in adult and pediatric patients whose fluid overload is unresponsive to medical management, including diuretics.

Contact Information

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

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.