FDA Identifies ICU Medical's Plum Duo Recall as Serious Type

ICU Medical ICUI is currently encountering a recall notice from the FDA for its Plum Duo Infusion System. The recall is for correcting certain devices with software issues, but does not involve removing the device from use.

The FDA recall notice last week warned that the Plum Duo Infusion System with software version 1.1.3 or earlier may cause the pump to stop responding because of a software problem. The agency has identified this recall as the most serious type as the pump may lead to serious injury or death in case of use without correction.

Please note that the Plum Duo Infusion System is available for delivery of parenteral fluids and medications through clinically acceptable routes, limited to intravenous, intra-arterial, and subcutaneous therapies in adult, pediatric and neonatal patient populations.  The device is intended for use in hospitals and outpatient healthcare facilities by licensed healthcare professionals.

ICU Medical is working to make corrections in the software and issued an Urgent Medical Device Correction notice to all affected users last month.

Price Performance

Although the FDA recall is an unfavorable event, shares of ICU Medical have remained steady as the recall notice does not lead to the withdrawal of the device. Rather, the faulty devices are advised to be quarantined until a software patch becomes available.

Shares of ICU have declined 17.7% so far this year against the industry’s 7.7% gain. The S&P 500 Index has increased 10.1% in the same period.

Correction Steps

The Plum Duo Infusion System with Unique Device Identifier of 400020401 and Model M335400021 with software version of 1.13 or earlier are the affected devices. The pump’s user interface is becoming unresponsive, possibly when the device experiences two sequences of programming events and alarm interactions. This unresponsiveness of the pump can potentially delay or interrupt the therapy.

The company also warns that use of the affected device can lead to delays in the initiation of therapy, over-delivery, interruption of therapy, or death. However, no injuries or deaths have been reported in relation to this issue.

ICU Medical has informed its users to identify affected pumps and quarantine them until a software patch is available, unless taking the devices out of circulation would result in a clinically meaningful pump shortage.

Meanwhile, ICUI has noted that if removing the pump from use could be detrimental to patient care, users are advised to carefully attend to the ‘CONFIRM STOP’ message that appears after pressing the ‘STOP’ button to avoid unintended interruptions. However, the pump must be exchanged and reprogrammed in case it becomes unresponsive.

ICU Medical, Inc. Price

ICU Medical, Inc. price | ICU Medical, Inc. Quote

ICUI’s Zacks Rank & Key Picks

Currently, ICUI carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space that have announced quarterly results are West Pharmaceutical Services, Inc. WST, Medpace Holdings, Inc. MEDP and Canopy Growth CGC.

West Pharmaceutical reported second-quarter 2025 adjusted EPS of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the Zacks Consensus Estimate by 5.4%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.8%.

Medpace Holdings, carrying a Zacks Rank #2 (Buy) at present, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.

Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 13.9%.

Canopy Growth reported first-quarter fiscal 2026 adjusted loss per share of 14 cents, which beat the Zacks Consensus Estimate by 6.7%. Revenues of $52 million surpassed the Zacks Consensus Estimate by 8.8%. It currently carries a Zacks Rank of 2.

Canopy Growth has an estimated growth rate of 83.2% for fiscal 2026. CGC’s earnings surpassed estimates in one of the trailing four quarters and missed thrice, the average negative surprise being 260.42%.

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This article originally published on Zacks Investment Research (zacks.com).

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