An unspecified number of ambulatory infusion pumps were recalled because of nearly 3,700 complaints related to several product issues, the FDA said March 20.
InfuTronix voluntarily recalled five types of its Nimbus Ambulatory Infusion Pump System after receiving 3,698 customer complaints between May 2019 and August 2023. The reports identified problems with battery power, medication infusion, potential leaks and flow rate.
The medical device company said a third-party health hazard evaluation deemed a low risk of product failure, but it is redesigning the system.
"Given the number of anticipated design improvements and the extensive requirement for design, verification and validation, InfuTronix believes a new premarket notification and clearance from FDA may be required," the March 20 post said.
InfuTronix said the infusion pumps are safe to continue using during the removal process, and healthcare providers were reminded on how to recognize a potential device failure.