An urgent recall has been issued for St. Jude Medical Inc.’s Riata and Riata ST. Silicone Defibrillator Leads. According to a notice posted on its website, the U.S. Food & Drug Administration (FDA) has deemed the St. Jude Riata defibrillator lead recall a Class I recall, its most serious type.
A defibrillator lead is a thin wire attached to the heart wall that delivers an electrical impulse via an implantable defibrillator. A potential risk of serious injury or patient death exists if the Riata defibrillator leads malfunction, according to the FDA. The recall was issued because wires inside some Riata leads can penetrate the insulation, compromising the device’s integrity. This may cause the devices to inappropriately shock some patients and fail to deliver necessary therapy to others, the company said.
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.
Patients who require frequent defibrillation or who are pacemaker dependent may be considered to be at greater risk if a Riata lead malfunctions, the company said. It recommended that doctors 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.
“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).
St. Jude said Riata leads remain implanted in an estimated 79,000 U.S. patients. Around 227,000 Riata defibrillator leads were sold worldwide.
Last December, we reported that St. Jude was phasing out the Riata leads because of these problems. According to that announcement, the rate of insulation abrasion was 0.47 percent nine years after the original implant, with 0.047 percent demonstrating “externalized cables. At that time, the FDA said a recall of the Riata leads wasn’t warranted.
In its latest letter set to physicians on November 28, 2011, St. Jude said the Riata lead defect is more prevalent than previously thought. The company is now putting the abrasion rate at 0.63 percent.