ICU Medical, Inc.

april 24, 2025

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Laurence D. King

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Kaplan Fox & Kilsheimer LLP is Investigating ICU Medical, Inc. (ICUI) for Potential Securities Law Violations

Kaplan Fox & Kilsheimer LLP is investigating potential securities violations against ICU Medical, Inc. (“ICU Medical” or the “Company”) (NASDAQ: ICUI).

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If you are an ICU Medical investor and have suffered losses, you may CLICK HERE to contact us. You may also contact Kaplan Fox by emailing pmayer@kaplanfox.com or by calling (646) 315-9003.

On April 22, 2025, Bloomberg reported that the Federal Drug Administration (“FDA”) had issued a Warning Letter to ICU Medical “regarding unapproved changes to its infusion pumps.”  The Warning Letter, dated April 4, 2025, which was based on an FDA inspection from July 23 through August 9, 2024, states that the Company “made multiple changes  to the Medfusion® Model 4000 Syringe Infusion Pump and CADD® Solis VIP Ambulatory Infusion Pump that could significantly affect the safety or effectiveness of these devices,” and that the Company “failed to submit a premarket notification submission to [the] FDA for significant changes or modifications that could significantly affect the safety or effectiveness of these devices. . . .” The Warning Letter further states that the pumps are “adulterated . . . because [the Company] does not . . . have an approved application for premarket approval (PMA) in effect.”

Following this news, the price of ICU Medical stock declined by as much as $10.72 per share, or by approximately 8%, during intraday trading. On April 22, 2025, ICU shares closed at $130.68 per share, a decline of $6.04 per share, or over 4%, from the closing price the prior day.

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If you have any questions about this investigation, please contact:

CONTACT:

Pamela A. Mayer
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(646) 315-9003
pmayer@kaplanfox.com

Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
lking@kaplanfox.com

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