A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
ICU Medical has issued an Urgent Medical Device Correction for its Plum Duo infusion system due to a software issue that may cause the pump’s user interface to become unresponsive. The US Food and Drug Administration (FDA) has classified this action as a Class I recall, indicating a risk of serious injury or death.
The software problem can occur following specific sequences of programming events and alarm interactions, potentially leading to a delay or interruption of therapy. According to the FDA notice, the use of an affected device could result in serious adverse health consequences, though no injuries or deaths related to this issue have been reported. The Plum Duo Infusion System is used in hospitals and outpatient facilities to deliver parenteral fluids and medications to adult, pediatric, and neonatal patients.
Corrective Actions and Recommendations
On July 1, 2025, ICU Medical sent a notice to all affected customers with instructions for managing the devices. The company recommends that healthcare facilities identify and quarantine all affected pumps until a software patch is made available.
If removing the devices from circulation would create a clinically significant pump shortage, facilities should implement a risk mitigation strategy. This includes ensuring that clinical staff carefully attend to the “CONFIRM STOP” message when stopping an infusion to prevent unintended interruptions. If a pump becomes unresponsive during use, it should be exchanged and reprogrammed immediately.
Customers with questions regarding the correction can contact ICU Medical Technical Support at 1-800-241-4002.
Photo caption: Plum Duo infusion system
File photo/ICU Medical
