Medical device maker ICU Medical changed designs of infusion pumps made in Minnesota without properly clearing important regulatory checks after a recent recall, according to a Food and Drug Administration warning letter this month.

The FDA noted that California-based ICU Medical, a multibillion-dollar device company, has clearance dating to the early 2010s for versions of two devices: the Medfusion Model 4000 Syringe and the CADD Solis VIP Ambulatory infusion pump. But the company failed to submit a premarket submission to the agency for “significant changes or modifications that could significantly affect the safety or effectiveness of these devices,” the agency said in its April 4 warning letter.

The devices are made at a former Smiths Medical ASD facility in the Twin Cities, which ICU acquired in 2022, the FDA said. Past recalls before the changes tied to the devices are linked to injuries and a death.

Changes made to the devices after the recall rendered them adulterated and misbranded because the modifications weren’t vetted with the FDA before deployment, the FDA letter says.

“Your firm should take prompt action to address the violations identified in this letter,” the agency said. “Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”

ICU acquired the Minnesota-based Smiths Medical division from Smiths Group for $2.35 billion in cash and stock in 2022, creating what it called a “leading IV therapy company” around the time. The device maker has faced several recalls related to its infusion pumps in recent years.

An ICU spokesperson said patient safety and regulatory compliance are top priorities. Commercial operations are continuing as usual, the spokesperson added.

“Since acquiring Smiths Medical, ICU Medical has invested hundreds of millions of dollars to improve quality and service at the Minneapolis-based manufacturer,” the spokesperson said.

The warning letter is the result of an FDA inspection occurring from July 23 to Aug. 9. The FDA said the company does not have an approved application for premarket approval or an investigational device exemption for the devices, regulatory hurdles that can take companies years to overcome.

The changed devices are misbranded, the FDA said, because the company did not tell the agency it intended to introduce or deliver them for broad commercialization.

ICU Medical has clearance for earlier versions of the two devices, the FDA said. “However, your firm has failed to submit a premarket notification submission to FDA for significant changes or modifications that could significantly affect the safety or effectiveness of these devices,” the agency continued.

The agency redacted the specific changes to the devices, as they contain potentially privileged or confidential trade secrets and commercial information. But the modifications, the agency said, can significantly affect infusion pump delivery and alarm functionality, the agency said.

The changes can also “affect the device’s risk profile for risks related to under- or over-infusion, delay in therapy, incomplete therapy, or false alarms leading to adverse health effects for patients such as overdose, volume overload, or cardiorespiratory compromise,” the agency said.

ICU issued updated software responding to a serious recall linked to issues affecting fluid delivery and false alarms without properly submitting required documentation in an application called a 510(k), the FDA said.

“Adding a statement to your labeling that the device software has not undergone FDA review is not sufficient,” the agency said.

The ICU spokesperson said 510(k) submissions are in progress for the two devices, “and we are committed to submitting in the next 90 days.” The spokesperson pointed out the company has received five 510(k) clearances for infusion systems in a little more than 18 months.

“We take our responsibilities seriously and are committed to ensuring all products from the acquired Smiths Medical business meet applicable regulatory requirements,” the spokesperson said.

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