Abbott (NYSE:ABT) announced today that it issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. This correction comes as a result of an issue that led to hundreds of severe adverse events, including seven deaths. Abbott — one of the largest diabetes tech companies in the world — […]
Recalls
ICU Medical issues infusion pump software correction labeled serious by FDA
The FDA issued a notice labeling a recall of ICU Medical (Nasdaq: ICUI) infusion pumps as the most serious type of recall. This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if […]
Baxter issues correction for some Novum IQ infusion pumps
Baxter (NYSE:BAX) has issued a letter to affected customers recommending a correction for its Novum IQ infusion pump systems. The correction applies to all Novum IQ large volume pumps (LVP) and syringe pumps (SP). Baxter said users should consider alternate pumps if available for care involving high-risk medications and/or critical illness. However, customers can continue […]
Medtronic issues CGM app warning in Spain
The Spanish Agency for Medicines and Medical Devices (AEMPS) has received notice of potential accessibility issues with Medtronic CGM apps. Medtronic Diabetes — soon to be MiniMed after its planned separation from the medtech giant – contacted users of certain Samsung Galaxy A13 smartphone devices, as those are used as a Medtronic smart monitoring receiver with […]
Tandem Diabetes Care issues insulin pump warning over potential speaker malfunction
Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated insulin pumps. In a July 22 notice, the San Diego-based company warned of pumps that may exhibit a higher rate of speaker failure. During normal use, the insulin pump software monitors current flowing through the speaker during use. Measurements […]
FDA warns on Baxter infusion pump issue that potentially led to deaths
The FDA issued an early alert related to an issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE:BAX). This notice comes just weeks after an initial warning about potential underinfusion with all Novum IQ large-volume pumps. That alert included reports of one serious injury and no deaths associated with the issue. Now, the FDA […]
Dexcom updates CGM receiver recall that led to serious adverse events
Dexcom (Nasdaq:DXCM) has issued an update related to a recall for its continuous glucose monitor (CGM) components. Last month, the FDA disclosed Dexcom’s recalls related to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature the established G6 and G7 sensors […]
BD issues voluntary recall on certain Alaris infusion pump modules
BD (NYSE:BDX) announced a voluntary recall related to certain Alaris and Alaris infusion pump modules. Affected Alaris products may have been serviced with previously recalled bezel kit assemblies. BD in 2019 recalled those kit assemblies manufactured between April 2011 and June 2017. They should not be used for service with the Alaris and Alaris Pump […]
Zyno recalls certain infusion pumps due to software issue
The FDA classified a recall of certain Zyno Medical infusion pump systems as the most serious kind as a result of a software issue. This recall involves removing certain devices from use or sale. As the most serious type of recall, it means the device may cause serious injury or death if its use continues. […]
Dexcom has a Class I CGM receiver recall
The FDA’s recall database today posted notices related to a Class I recall for continuous glucose monitor (CGM) components made by Dexcom (Nasdaq:DXCM). Dexcom’s recalls relate to its Dexcom One and One+ offerings and the G6 and G7 CGMs. The One and One+ systems, which are mainly the company’s commercial CGM offering outside the U.S., feature […]
