The FDA says ICU Medical failed to submit required notifications for device changes that could impact patient safety.
By Alyx Arnett
The US Food and Drug Administration (FDA) has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps: the Medfusion Model 4000 Syringe Infusion Pump and the CADD Solis VIP Ambulatory Infusion Pump.
Following an inspection conducted between July 23 and Aug 9, 2024, at a Minneapolis facility acquired by ICU Medical through its 2022 purchase of Smiths Medical, the FDA found that the company had made significant changes to the devices without submitting the required premarket notifications. According to the agency, the modifications—including software updates intended to address safety concerns—could significantly affect the pumps’ safety and effectiveness.
Both devices were previously cleared by the FDA under earlier 510(k) submissions, in 2011 for the Medfusion Model 4000 and in 2013 for the CADD Solis VIP. However, the FDA said ICU Medical failed to notify the agency of later changes that potentially impact the pumps’ risk profiles, including risks of under- or over-infusion, therapy delays, and false alarms that could lead to serious patient harm such as overdose or cardiorespiratory compromise.
The FDA also noted that some of the changes were part of a Class I recall response addressing issues with fluid delivery, therapy interruptions, and false alarms. Despite identifying new or significantly modified risks during its internal assessments—risks that, according to company procedures, would require a new 510(k)—ICU Medical had not submitted updated applications to the agency.
“Adding a statement to your labeling that the device software has not undergone FDA review is not sufficient,” the agency wrote in the warning letter dated April 4, 2025.
ICU Medical was given 15 business days to respond with specific steps it has taken to address the violations and prevent similar issues from recurring. Failure to do so could result in regulatory actions such as seizure, injunction, or civil money penalties, the FDA said.
In response to a request for comment, ICU Medical told 24×7 that patient safety and regulatory compliance remain its top priorities. The company noted it has invested hundreds of millions of dollars to improve quality and service since acquiring Smiths Medical and that new 510(k) submissions for the CADD and Medfusion pumps have been in progress, with plans to submit them within the next 90 days.
ICU Medical also highlighted that an August 2024 FDA inspection tied to a prior 2021 warning letter for Smiths Medical was completed with zero observations and pointed to recent 510(k) clearances as evidence of its strong standing and communication with the agency. Commercial operations remain business as usual, the company says.
ID 193396128 © Alexey Novikov | Dreamstime.com
