After multiple issues and more than 3,500 complaints logged over four years, InfuTronix is pulling some 52,000 of its Nimbus II infusion pump systems from the market and opting for a complete redesign.
The FDA elevated the voluntary device removal with a public safety announcement earlier this month before handing the action a Class I recall label March 28, the agency’s most serious designation. The company will cease supporting the systems June 20.
The Nimbus II family of portable pumps are used to deliver slow doses of drugs such as chemotherapies as well as patient-controlled releases of painkiller medications following a surgical procedure.
According to the agency, reported complaints have included: drops in battery power, with brownouts resulting in the pump abruptly shutting off; blocks in the flow of medication through its infusion sets; software errors that pause doses; leaks; and unwanted changes in flow rate.
The FDA also cited the design of the pump housing itself, which weighs less than half a pound in total, where damage over time to its tubing connections have led to false occlusion alarms and potentially inaccurate doses.
Massachusetts-based InfuTronix has already notified customers with a letter of its own. The planned redesign is slated to address the Nimbus’ mechanics, electronics, software and pump housing—changes that the company says will eventually require a new clearance from the FDA.
The agency said that, in the meantime, it considers the Nimbus pump and its infusion sets safe to use, though healthcare providers should be aware of the signs of a potential issue. An independent evaluation found that the most common failure modes posed a low risk to users, according to the FDA.
InfuTronix previously received an agency warning letter in June 2022 over its Nimbus pumps, after an inspection of its Natick facility found deviations from good manufacturing practice requirements. The FDA also cited the company for not launching corrective and preventive action procedures, or CAPAs, following reports of battery issues, flow set problems and leaks.
That year, the FDA also delivered a warning letter to Zyno Medical—a large-volume infusion pump and tubing set manufacturer located at the same Massachusetts address and listing the same CEO and founder, Chaoyoung Lee—over similar CAPA issues. Both InfuTronix and Zyno are owned by the infusion pump distributor Intuvie.