This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if the customer fails to make the necessary correction.
ICU Medical identified a software issue with its Plum Duo infusion system with software version 1.1.3 and earlier. The software can potentially result in the pump becoming unresponsive. Pumps may experience two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. This may result in the delay of therapy or interruption of therapy.
Using affected systems may cause serious health consequences. Those may include delay in the initiation of therapy, over-delivery, interruption of therapy or death. ICU Medical reports no injuries or deaths related to the issue to date.
On July 1, 2025, the company sent all affected customers an urgent medical device correction. It recommended that users quarantine affected devices until the company makes a patch available. The company plans to develop a patch and schedule software updates for pumps as needed.
Plum Duo delivers parenteral fluids and medications through clinically acceptable routes (limited to intravenous, intra-arterial, and subcutaneous therapies). It’s intended for use in hospitals and outpatient healthcare facilities by licensed healthcare professionals. Its indications include adult, pediatric (both infants and children) and neonatal patient populations.
ICU Medical launched “a new category of infusion pumps” that included the Plum Duo in April.
