In October 2016, the U.S. Food and Drug Administration (FDA) issued a recall notice after 13 models of defibrillation devices contained faulty lithium batteries. The defects took place when lithium deposits formed in the batteries, causing those batteries to stop working. An updated safety warning was added in August 2017.
Fortify, Unify, and Assura models of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) were all on the FDA’s defibrillator recall list. The FDA has also stressed this is a Class I recall, the most serious type.
