Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System

Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System

Natick, MA, March 20, 2024 – InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the Nimbus Infusion Pump systems dated May 2019 to August 2023. Evaluation of complaint data has identified several potential product issues:

• Battery Power may potentially affect the performance of the pump by causing an immediate power off event.
• Upstream Occlusion, as noted by the upstream occlusion alarm, occurs when there is a block in flow of the proximal end of the administration set.
• System Errors, as noted by the System Error alarm which causes the pump to suspend the infusion.
• Drug product egress from certain administration set bonding points, which may potentially result in drug product leaking from the device.
• Flow Rate (high or low) which may potentially lead to the pump infusing an inaccurate delivery of the drug.
• Pump Housing design which may potentially result in damage over time to certain areas of the housing responsible for administration set engagement, leading to false occlusions and flow rate inaccuracies.