Medtronic has recalled more than 204,000 devices used to assist hospital and other patients with end-stage heart failure due to the potential for power source interruptions, the Food and Drug Administration reported Friday. The HeartWare Ventricular Assist Device is used as a bridge to cardiac transplantation in patients who are at risk of death from end-stage left ventricular heart failure. Health care professionals and consumers may report adverse reactions and quality problems with the devices to the FDA’s MedWatch program. For more information, see the recent Medtronic letter to health care providers.

Headline
The Food and Drug Administration has issued an early alert for all automated Impella controllers by Abiomed following an issue that has caused three deaths and…
Headline
Boston Scientific, a large supplier of medical devices, said in an Aug. 26 statement posted on its website that on Aug. 25 it “identified a cybersecurity…
Headline
The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility…
Headline
The Food and Drug Administration has identified a Class I recall of North American Rescue first aid kits containing TRUE METRIX Blood Glucose Monitoring…
Headline
The Food and Drug Administration June 16 announced that a nationwide shortage of stereotactic breast biopsy needles is expected to last through the end of…
Blog
High-quality maternal care is essential to protecting the health of both mom and baby during birth.Sutter Health is taking a proactive, systemwide approach to…