FDA Identifies ICU Medical's Plum Duo Recall as Serious Type

Core Insights - ICU Medical (ICUI) is facing a recall notice from the FDA for its Plum Duo Infusion System due to software issues, but the recall does not require the device to be removed from use [1][5][8] FDA Recall Details - The FDA has classified the recall as the most serious type, warning that the affected Plum Duo Infusion System with software version 1.1.3 or earlier may cause the pump to stop responding, potentially leading to serious injury or death if not corrected [2][8] - The affected devices are identified by Unique Device Identifier 400020401 and Model M335400021, with the software version of 1.13 or earlier [6][9] Device Usage and Impact - The Plum Duo Infusion System is designed for delivering parenteral fluids and medications through intravenous, intra-arterial, and subcutaneous routes in various patient populations [3] - ICU Medical has advised users to quarantine the affected pumps until a software patch is available, emphasizing that if removing the device could harm patient care, users should monitor the 'CONFIRM STOP' message to prevent unintended interruptions [10][9] Company Response and Market Performance - ICU Medical is actively working on software corrections and has issued an Urgent Medical Device Correction notice to all affected users [4] - Despite the recall, ICU Medical's shares have remained steady, with a year-to-date decline of 17.7%, compared to a 7.7% gain in the industry and a 10.1% increase in the S&P 500 Index [5]