FDA Warns ICU Medical Over Unapproved Changes to Infusion Pumps

The U.S. Food and Drug Administration (FDA) issued a warning letter to ICU Medical in April, citing the company for failing to submit required premarket notifications after making multiple changes to its Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump. Inspectors found that these modifications—intended to address issues identified in adverse event reports and a Class I recall—could significantly impact device safety and effectiveness, affecting infusion accuracy, alarm performance, and overall therapy delivery.

The FDA criticized ICU Medical for bypassing the 510(k) clearance process, even though the company’s internal assessments acknowledged increased or modified risk profiles. Labeling the updated software as unreviewed was deemed insufficient.

This warning comes amid ongoing regulatory scrutiny following ICU Medical’s 2022 acquisition of Smiths Medical, which has faced multiple recalls. The FDA has recently taken similar actions against Abbott, Q’Apel Medical, and Renovo, reinforcing stricter enforcement around device modification reporting.

05-05-2025