St. Jude Medical sent a letter to doctors in November advising that several hundred of its Optisure dual-coil defibrillator leads may not work because of damaged insulation on the leads. The insulation on the leads may have been damaged during the manufacturing process. The Optisure lead recall was then announced by the FDA and classified as a Class 1 Advisory. A Class 1 recall means the FDA believes using one of the devices could result in serious health consequences.… Read More