FDA Issues First Early Alert with Fresenius Kabi Infusion Pump Recall

Fresenius Kabi has initiated a recall of certain Ivenix large-volume infusion pumps due to faulty pneumatic valves that may trigger alarms, potentially disrupting critical treatments. The FDA, leveraging its new early alert program, quickly notified the public about the issue just days after Fresenius informed healthcare providers. The affected pumps are used to deliver vital fluids, such as medications or blood products, in hospitals and outpatient settings. While no injuries or deaths have been reported, the risk of treatment interruptions could result in severe consequences, including permanent disability or death, in life-sustaining cases. Healthcare facilities are advised to immediately remove the impacted devices or closely monitor patients using them until replacements are available.

This marks the first alert under the FDA’s early recall communication program, designed to expedite awareness of high-risk device issues. In the past, such notices could take weeks or months, but the FDA acted within six days of Fresenius’ initial warning. With over 1,500 devices impacted, the recall adds to a year of scrutiny for the Ivenix pumps, which previously faced Class I recalls for issues like uncontrolled medication flow and software malfunctions. Fresenius has not disclosed the total number of affected devices, but healthcare providers are urged to follow strict safety protocols to avoid inadvertent use.