The Riata and Riata ST family of silicone defibrillation leads have exhibited an insulation abrasion rate of 0.47% over 9 years of use. Silicone rubber, while representing the industry’s most commonly used defibrillation lead insulation material over the past 20 years, has been observed to be vulnerable to abrasion. Abrasion of silicone defibrillation leads is acknowledged within the clinical community as a well known clinical risk and is well documented in the literature as the number one cause of lead failure across the industry with reported failure rates ranging from 3 to 10 %. Lead insulation damage and its possible effects are also described as a potential adverse event in all silicone defibrillation lead user’s manuals, including Riata User’s manuals.Later St. Jude lead designs with their newer "Optim" polymer insulation appear to not be affected by this action. St. Jude had hoped their Riata line of defibrillator leads could replace the niche left by Medtronic's earlier withdrawl of their downsized Sprint Fidelis defibrillator leads after Medtronic's line of 7Fr defibrillator leads experienced higher-than-expected fracture rates.
Just as with the Medtronic Sprint Fidelis defibrillator lead withdrawl, St. Jude does not recommend the affected leads be extracted. I would suspect that doctors will weigh the risks vs. benefits of placing a new defibrillator lead at the time of device battery changes.
In November 2007, the Riata line of defibrillator leads were plagued by concerns of a higher-than-average rate cardiac perforation, but these were quickly disputed by the company.