Following the voluntary removal, the FDA deemed the recall Class I, the most serious kind. It affects 52,328 devices in the U.S. in total.
The recall extends to the Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS. InfuTronix initiated the recall in response to 3,698 customer complaints related to its infusion pump system. Complaints from May 2019 to August 2023 identified “several potential product issues,” according to InfuTronix.
Among the problems, the company identified that battery power may potentially affect the performance of the pump by causing an immediate power off event. Upstream occlusion, system errors, drug product egress and inaccurate drug delivery may occur as well. InfuTronix also said its pump housing design may potentially result in damage over time to certain areas responsible for administration set engagement. This could lead to false occlusions and flow rate inaccuracies.
The company identified the product issues through the post-market surveillance system. InfuTronix said it determined that its best corrective and preventive action is a redesign of the Nimbus system. The company expects to need a new premarket notification and FDA clearance for this redesigned system. As a result, it wants to remove the Nimbus system from the market while it seeks the new clearance.
InfuTronix plans to cease availability and support for the system after June 20, 2024.
