Device and Drug Alerts

FDA: Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
FDA: Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software
FDA: Cook Medical Issues Voluntary Recall of Transseptal Needle and Transseptal Needle with Catheter
FDA Class I Recall: Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use
FDA: Medtronic Expands Recall of MiniMed 600 Series Insulin Pumps for Incorrect Insulin Dosing
FDA: Medtronic Expands Recall of Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue
FDA: Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men – Letter to Health Care Providers
FDA: Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency
FDA Requires Warnings about Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and Death for JAK Inhibitors that treat Certain Chronic Inflammatory Conditions