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FDA declares OptumHealth’s infusion system recall as Class I

The FDA has issued a Class I recall for OptumHealth's infusion systems, the most severe classification, affecting 208 devices distributed in the US between August 2020 and April 2024. These pumps administer medications or fluids through subcutaneous, intravenous, or perineural and epidural routes, primarily in healthcare settings but also in patient homes.

OptumHealth initiated the recall after InfuTronix recalled the Nimbus administration set, including the Nimbus II Plus, due to multiple failure modes such as battery failure and drug product leakage. The FDA warned of potential interruptions in therapy, contamination, and risks like organ failure and seizures.

While InfuTronix reported numerous complaints, OptumHealth noted no additional injuries or deaths. They plan to replace faulty pumps for patients and advise using new batteries and avoiding turning the device off/on to clear alarms until replacements arrive.

This recall mirrors Baxter's recall last year, further highlighting safety concerns in the growing $3.3bn infusion pump market, where Baxter holds a significant market share.