FDA And Nuwellis Address Potentially High-Risk Issue With Blood Circuit Device

The FDA is addressing a potentially high-risk issue linked to certain lots of the AquaFlexFlow UF 500 Plus extracorporeal blood circuit, a device produced by Nuwellis Inc NUWE.

The device, used with the Aquadex SmartFlow and FlexFlow Systems, has been associated with potential safety concerns.

The AquaFlexFlow UF 500 Plus blood circuit is designed for single use. It is utilized for continuous ultrafiltration therapy in adult and pediatric patients with fluid overload who are unresponsive to standard medical treatments like diuretics.

Nuwellis has initiated a recall, urging healthcare providers to cease use of specific product lots to prevent risks.

On December 11, 2024, Nuwellis notified affected customers of the issue and recommended immediately discontinuing impacted device lots to mitigate injury risks.

Customers were instructed to verify lot numbers on the product labeling to identify affected devices and ensure proper disposal. Additionally, users were advised to heed console alarms and avoid overriding alerts during device operation.

The concern arises from alarms indicating "Ultrafiltrate Weight Mismatch" or "Excessive Weight Mismatch" while the device is in use.

These warnings signal potential problems with fluid removal accuracy. If excessive weight mismatch alarms occur, the console terminates therapy, potentially leading to acute volume depletion.

This condition, which may cause dehydration or hypovolemia, poses significant risks, particularly for pediatric patients. Continuing therapy requires priming a new blood circuit.

Nuwellis has reported three injuries linked to this issue so far.

Price Action: NUWE stock closed at $1.12 on Monday.

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