Medical Device Network

FDA tags OptumHealth’s infusion system recall as Class I

The tag follows InfuTronix’s recall of the Nimbus administration set in April.

The US Food and Drug Administration (FDA) has classified OptumHealth’s recall of infusion systems as Class I, the most severe designation available.

A total of 208 devices distributed in the US between August 2020 and April 2024 have been recalled.

The pumps deliver medications or fluids to a patient via subcutaneous, intravenous, or perineural and epidural administration. While the pumps are mainly used in hospitals and other healthcare facilities, they can also be used in patient homes.

Last month, US-based OptumHealth initiated a recall of its Optum Nimbus II Plus Ambulatory infusion systems after InfuTronix recalled the Nimbus administration set, which included the Nimbus II Plus, in the same month.

The infusion set experienced multiple failure modes, including battery failure, upstream blockage, and drug product leakage, among others. The FDA stated this could lead to interruptions in therapy, microbial contamination, and danger to the patient such as organ failure and seizures.

The FDA tagged the recall as Class I as continued use of a device could result in serious injury or death.

At the time, InfuTronix reported 3,698 complaints, six serious injuries, and one death.

OptumHealth reported no additional injuries or deaths in its recall. The company said it plans to replace faulty infusion pumps with an alternative for patients currently receiving care. Until then, OptumHealth recommends only using new batteries as replacements, not turning the device on and off to clear an alarm and carrying the drug product dispensing pouch in a carrying pack.

Another high-profile recall occurred in the infusion pump space last year when Baxter recalled nearly 23,000 devices due to software issues. The FDA also tagged that recall as Class I due to three serious injuries but no deaths.

The infusion pump market is expected to grow to $3.3bn by 2033, up from $2.6bn in 2023, according to analysis by GlobalData. Baxter has the largest global market share in the device space.

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