FDA issues update on Medtronic’s HeartWare Ventricular Assist Device system
The Food and Drug Administration yesterday provided an update on the HeartWare Ventricular Assist Device system. These updates include new recommendations for patients and providers; information related to FDA’s actions following a June 2022 recall related to battery electrical faults; details on recent recalls conducted by Medtronic including new ways to reduce damage to controller port pins; and information on the system’s pump weld defect.
Related News Articles
Headline
Despite elegant efforts to design for safe use, rigorous standards and regulatory requirements, and lots of training of health care professionals, there’s…
Headline
The Trump administration yesterday announced it issued executive orders authorizing 25% tariffs on all steel and aluminum imports. Importantly, both steel and…
Headline
The Food and Drug Administration Feb. 5 released an alert notifying patients of a safety concern using diabetes devices such as continuous glucose monitors,…
Headline
The Department of Health and Human Services Sept. 30 released a statement on the dockworker strike at ports along the East and Gulf coasts, saying that…
Headline
The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devices needing…
Headline
The Government Accountability Office Dec. 21 recommended the Food and Drug Administration and Cybersecurity and Infrastructure and Security Agency update a 5-…