The FDA recently labeled Smiths Medical’s recall of some ventilators as Class I, the most serious kind. ICU Medical’s Smiths Medical initiated a recall of some ASD PneuPac paraPAC Plus 300 and 310 Ventilator kits on February 7. The company said the ventilators may intermittently provide continuous positive gas flow instead of the intended cycling […]
ICU Medical
Smiths Medical recall affects nearly 86,000 syringe pumps with software issues
Smiths Medical issued a recall for its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions. The ICU Medical unit issued the recall as a correction — not a product removal. It affects 85,961 pumps distributed between Aug. 9, 2022, and Aug. 15, 2023. Smiths Medical initiated the infusion syringe pump […]
Layoffs in medtech: These companies recently reduced their workforce
The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs. You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more. For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply […]
ICU Medical stock falls on Q3 revenue miss
ICU Medical stock is down today after a third-quarter earnings report that included a revenue miss. ICUI shares were down more than 15% to $86.68 apiece by midday trading today. MassDevice‘s MedTech 100 Index was down slightly. San Clemente, California–based ICU Medical — maker of infusion systems, infusion consumables and critical care products — announced […]
FDA clears new infusion pump and software from ICU Medical
ICU Medical announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software. The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024. Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on the […]
ICU Medical to close Minnesota facility, cut 81 jobs
ICU Medical filed with the state of Minnesota to confirm a facility closure and some layoffs. Layoffs continue to impact the medtech industry as companies battle ongoing economic challenges. Over the past year or so, MassDevice has reported on around 18,000 job cuts across the industry. Minnesota’s State Rapid Response Team received a Worker Adjustment and […]
ICU Medical recalls certain infusion pump replacement batteries
The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind. ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems. The infusion systems […]
Report: ICU Medical, GE HealthCare to battle over Medtronic units
Reuters reported today that ICU Medical and GE HealthCare are pursuing two business units Medtronic aims to sell off. The outlet cites sources familiar with the situation, saying the companies are looking at Medtronic’s patient monitoring and respiratory interventions businesses. According to Reuters, Medtronic values these businesses between $8 billion and $9 billion. In October, Medtronic […]
ICU Medical stock slides on mixed Q4, projected 2023 losses
ICU Medical (Nasdaq:ICUI) shares took a hit today on fourth-quarter results that came in mixed compared to the consensus forecast. Shares of ICUI fell 6.2% at $166.70 apiece just after the market opened today. The San Clemente, California-based company posted losses of $15.5 million in the quarter. That amounts to 65¢ per share on sales […]
Smiths Medical issues urgent device correction for some CADD infusion pumps
Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system. The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no […]
10 big earnings stories from the last quarter: How are medtech stocks doing now?
Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results. Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces […]