The US Food and Drug Administration (FDA) has issued an alert relating to a problem with blood circuit sets manufactured by Nuwellis that may be “high-risk”.
Nuwellis sent affected customers an Urgent Medical Device Advisory Notice letter on 11 December, with the FDA alert coming on the 30 December, as part of a communications pilot to enhance medical device recalls.
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Shares in Nasdaq-listed Nuwellis were down 2.56% at market open on 30 December, though the FDA issued its alert after the market closed. Nevertheless, shares in the company are down nearly 15% from 11 December.
The early alert relates to AquaFlexFlow UF 500 Plus extracorporeal blood circuit, a single use device that removes blood from a patient’s body, processes it, and returns the blood to the patient. AquaFlexFlow UF 500 Plus is used with the Aquadex SmartFlow Systems, indicated for continuous ultrafiltration therapy for use in adult and paediatric patients who do not respond to other approaches, such as diuretics, for fluid overload.
The AquaFlexFlow UF 500 Plus has been found to indicate two types of weight mismatch alarms whilst in use – if these alarms build up then the Aquadex console terminates the therapy with the blood circuit. As per the FDA alert, therapy termination can cause excess fluid removal from a patient, leading to acute volume depletion. This is also known as hypovolemia and is especially serious in paediatric patients.
US-based Nuwellis has reported three injuries due to this issue, though the FDA has not issued a recall yet. The agency said it is “aware of a potentially high-risk device issue” and that it will “keep the public informed and update [the early alert webpage] as significant new information becomes available.”
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By GlobalDataIn the letter to customers of the AquaFlexFlow UF 500 Plus, Nuwellis recommended immediately discontinuing use of affected lot numbers.
Nuwellis, which has a market cap of $4.9m, nearly lost its listing on Nasdaq due to non-compliance with the minimum bid price rule earlier this year. Earlier this month, the company announced it had regained compliance, securing its future on the stock exchange.
