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 […]
Recalls
Medtronic Diabetes unit fully resolves FDA warning letter
Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters. In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters. The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of […]
Abbott FreeStyle Libre reader warning affects more than 4 million devices
The FDA today issued a notice classifying a recall of Abbott (NYSE:ABT) FreeStyle Libre readers as Class I, the most serious kind. Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from […]
Abbott warns on some FreeStyle Libre readers due to battery issues
Abbott (NYSE:ABT) initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The instructions cover the FreeStyle Libre, Libre 14-day and Libre 2 readers in the U.S. Abbott received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or […]
iRadimed issues urgent field safety notice for some infusion pump syringe adapters
iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets. The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, […]
BD issues vulnerability warning for Alaris infusion monitoring software
BD (NYSE:BDX) today issued a voluntary notification regarding cybersecurity vulnerabilities with its Alaris Infusion Central software. Alaris Infusion Central, a standalone software — separate from pumps — provides data from the Alaris pumps. It allows healthcare providers to monitor infusion data sent from Alaris Plus and Alaris neXus pumps on a computer. Alaris Infusion Central […]
The 10 biggest diabetes tech stories from 2022
2022 represented a landmark year for next-generation diabetes tech. Here are the biggest stories from the past year. Some companies picked up major regulatory nods. Others experienced major regulatory setbacks. Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from in the world of diabetes tech, […]
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 […]
FDA says Insulet Omnipod Dash batteries recall is Class I
The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level. Insulet recently issued a voluntary global safety notice to warn about battery problems. The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. The […]
Insulet issues device correction on Omnipod 5 controller due to charging issue
Insulet (Nasdaq:PODD) announced a medical device correction for its Omnipod 5 automated insulin delivery system. Acton, Massachusetts-based Insulet’s correction relates to an issue with the Omnipod 5 controller’s charging port and cable. The correction does not impact the Omnipod 5 pod, the previous-generation Omnipod Dash and Omnipod, or compatible Android smartphone devices with the Omnipod 5 […]
