MedSun Newsletters

MedSun Newsletters

Infant/Child Reduced Energy Defibrillation Electrodes by Cardinal Health: Voluntary Field Action  The company is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by Cardinal Health, which shows incorrect electrode placement for an infant. There is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging... Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers The FDA issued an update to the March 18, 2017 letter to health care providers to inform the health care community that interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated with the approved metallic XIENCE drug-eluting stent… Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication St. Jude Medical notified physicians of the availability of Battery Performance Alert (BPA), a new battery performance management tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion in implantable cardioverter defibrillators... Infant Sleep Positioners: FDA Warning FDA is reminding parents and caregivers not to put babies in sleep positioners. These products—sometimes also called “nests” or “anti-roll” products—can cause suffocation that can lead to death…