The U.S. Food and Drug Administration (FDA) issued a warning letter to ICU Medical, Inc. on April 22, 2025, stating that the company had made multiple changes to its Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump without submitting required premarket notifications. The FDA indicated that these modifications could significantly affect the safety or effectiveness of these devices.
The warning letter specified that the subject pumps were deemed 'adulterated' and 'misbranded' due to the unapproved changes. The FDA noted that the modifications could significantly impact the functionality of the device, including the infusion pumps' delivery profile and alarm functionality, thereby affecting the devices' risk profile.
This regulatory action requires ICU Medical to undertake remediation efforts and obtain new 510(k) clearances for the affected pumps. The outcome and financial impact of these efforts remain uncertain, and delays or unfavorable outcomes could impact the company's ability to sell or market these critical products, posing a significant challenge to its operations.
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