InfuTronix Announces Voluntary Recall of Nimbus Ambulatory Infusion Pump System

InfuTronix, LLC has initiated a voluntary recall of its Nimbus Ambulatory Infusion Pump System in the US, citing 3,698 customer complaints from May 2019 to August 2023. The recall includes models Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD, and Nimbus II EMS due to potential product issues such as battery power affecting performance, upstream occlusion, system errors, drug product egress from the administration set, variable flow rate, and pump housing design flaws. These issues could lead to inaccurate drug delivery or device leakage.

The identified problems were revealed through post-market surveillance and further evaluated by InfuTronix's Corrective Action/Preventive Action (CAPA) system. In response, InfuTronix plans to redesign the Nimbus system to enhance its mechanics, electronics, software, and housing design, which may require FDA re-clearance. An independent health hazard evaluation has deemed the device's common failure modes as posing a low risk to users. The product has been distributed across the US since October 17, 2014, but never internationally.

While the recall is underway, users can continue using the Nimbus system but should remain vigilant for signs of potential failure, as detailed by InfuTronix. Healthcare providers are advised to adhere strictly to the instruction manual, educate patients on proper use, and establish contingencies for possible device malfunctions. Affected customers are encouraged to contact InfuTronix for information on returning the products by June 20, 2024, after which the products will no longer be supported.