Class 1 recall announced for ambulatory infusion pump

Editor's Note

The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death.

According to the agency’s May 30 announcement, the company recalled the pumps in direct response to an earlier recall of the same products by InfoTronix due to multiple potential failure modes, including upstream blockage (occlusion), system errors, drug product leakage, high or low flow rate, or damaged housing. The devices will not be available or supported after June 20, 2024.

In an April 28 notification letter, OptumHealth informed customers about plans and expectations for replacing the pumps and recommended actions to take in the meantime, such as using only new batteries and avoiding cycling the batteries.