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, […]
Recalls
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 […]
Insulet warns of battery issues with some Omnipod Dash PDM devices
Insulet (Nasdaq:PODD) recently issued a voluntary global safety notice to warn of battery problems with its Omnipod Dash system. 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. Insulet’s notice went out to current and past users of the Omnipod Dash […]
Medtronic, FDA warn on potential cybersecurity risk with MiniMed insulin pump
Medtronic (NYSE:MDT) issued an urgent medical device correction notice to warn of potential issues with some MiniMed automated insulin delivery systems. The notice — dated this month — covers the company’s MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose […]
Recall of Baxter Clearlink due to risk of leaks is Class I
The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind. Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy […]
Medtronic warns on Prevail Paclitaxel-coated PTCA balloon catheter
Medtronic this week issued an urgent field safety notice for some of its Prevail Paclitaxel-coated PTCA balloon catheters. The Fridley, Minnesota-based company issued the warning due to the potential for an incorrect compliance chart attached to the catheter hoop. The balloon size on the compliance chart differed from the balloon size detailed on the packaging, […]
Intera Oncology has a serious infusion pump recall
The FDA today warned that the recall of an infusion pump from Intera Oncology is Class I, the most serious kind. Intera recalled the Intera 3000 hepatic artery infusion pump after receiving reports from clinicians that the pumps were delivering medications (flow rate) faster than expected. If the pump delivers infusions at faster than expected flow […]
Smiths Medical warns on potential issue with fluid warmers
Smiths Medical announced today that it issued an urgent medical device correction letter regarding its Level 1 Fast Flow fluid warmers. Minneapolis-based Smiths Medical’s Level 1 H-2 pressure chambers used with the Level 1 Fast Flow fluid warmers could potentially impact the pressure exerted onto an IV fluid bag while contained within the pressure chamber, […]
