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.
About Defibrillation Devices
Defibrillation is a common treatment for life-threatening cardiovascular irregularities, often used during cardiopulmonary resuscitation (CPR).
The first ICDs were implanted at John Hopkins Hospital in February 1980, and they have since been administered to patients suffering frequent heart problems, or those who’ve experienced a cardiac episode.
ICDs work like pacemakers. They are implanted under the skin in the upper chest, monitoring heart rate and delivering small electrical pulses when needed. CRT-Ds, a type of ICD, work by sending electrical pulses to both lower heart chambers so they may beat with more synchronicity.
Continuing Defibrillation Device Risks
If defective batteries weren’t enough of a concern, implant procedure of CRT-Ds also comes with risks, including blood clots, punctured lungs, and dangerous arrhythmias.
The original October 2016 FDA defibrillator recall notice also contained information about a new battery performance management tool called Battery Performance Alert (BPA).
St. Jude notified physicians about it in the August 2017 FDA safety update, saying, “If a BPA is triggered for a patient’s device, the patient’s physician will be notified through the device programmer and/or the […] monitoring system. St. Jude Medical recommends immediate device explant and replacement.”
More than 175,000 defibrillation devices have been recalled across the U.S. since they were last manufactured in May of 2015. St. Jude Medical continues to be one of the nation’s largest producers of heart devices.