FDA orders St. Jude to conduct 3-year review on Riata, Durata and other leads
The FDA orders St. Jude Medical to conduct a 3-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as 3 additional sets of leads not associated with the recall.
The FDA ordered St. Jude Medical (NYSE:STJ) to launch a 3-year postmarket review on its recalled Riata and Riata ST defibrillator leads as well as for its QuickFlex LV CRT, QuickSite LV CRT, Riata ST Optim and Durata leads.
That's bad news for the medical device giant, which has worked hard to distance its leads, especially the Durata, from the high-profile Riata recall.
The FDA slapped the cardiology device maker with a Class I recall on the Riata leads in December 2011 after the company said they failed more frequently than previously reported. St. Jude recalled the Riata leads after receiving reports of high rates of "insulation abrasion," which occurs when the leads' wires poke through their insulation. St. Jude started pulling the devices off the shelves a year earlier over the same concerns.