St. Jude Recalls Riata Leads, Says Defect Rate Higher Than ThoughtDec 16, 2011 | Parker Waichman LLP
A year after stopping sales of its Riata family of defibrillator leads, St. Jude Medical Inc. is officially recalling the defective devices. The ST. Jude Riata defibrillator lead recall has been deemed Class I by the U.S. Food & Drug Administration (FDA), meaning the leads pose a risk of serious injury or death.
According to the recall notice, Riata and Riata St. Silicone leads are being recalled because the wires can penetrate their insulation. When this occurs, the implantable defibrillator may not deliver shocks to the heart when it's needed. In other cases, the defibrillator may deliver unnecessary shocks.
Last December, when St. Jude announced it was phasing out the Riata leads, it said the abrasion rate was around 0.047 percent. In a letter sent on November 28 to doctors, the company acknowledged that the defect is more prevalent than first thought, and increased the abrasion rate to 0.063.
Despite the phase-out, Riata leads remain implanted in an estimated 79,000 U.S. patients. Around 227,000 Riata defibrillator leads were sold worldwide.
So far, two deaths and one serious injury have been reported in connection with attempts by doctors to remove Riata lead wires. In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors, St. Jude said.
The company has advised doctors to continue monitoring their patients' implanted defibrillator systems and use X-rays or fluoroscopy if there is evidence of a lead electrical failure. The potential risks associated with externalized conductors as well as the potential risks and benefits of management options should be considered and discussed with patients. St. Jude isn't advising doctors on whether or not defective leads should be removed.
“At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard practice of care to manage their patients with Riata silicone leads,” said Dr. Anne Curtis, professor and chair of Medicine at the University at Buffalo, former Heart Rhythm Society (HRS) president and a member of St. Jude Medical’s Medical Advisory Board (MAB).