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

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.

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