St. Jude Medical is facing reports that its next-generation Durata defibrillator leads may be defective in that they fray and become exposed. Controversy over the Durata leads started in 2010 over safety concerns and a follow-up study leads to an FDA Class 1 recall late that year. Apparently the recent defect report was filed by a physician in the FDA’s MAUDE database and is under review. The Durata defibrillation Lead was designed to pass through crowded veins and provide greater access as it is smaller in size. Defective leads can cause injury and death. Medtronic Inc. removed its Sprint leads from the market after five patient deaths were linked to the devices. A fractured leads can cause unecessary shocks to the hear or not operate at all.