Issues with St. Jude Medical's Riata heart defibrillator have prompted the Food and Drug Administration to recommend that patients with the device get X-rays to check for abnormalities.
Defibrillators are stopwatch-sized devices that shock an errantly beating heart back into rhythm. Implanted in the upper chest, they are connected to the heart by leads, or insulated wires.
Little Canada-based St. Jude pulled its popular Riata leads off the market in December 2010, and the FDA issued a recall of the device in late 2011, after St. Jude sent a letter to physicians telling them about a possible problem related to the device.
Reports had surfaced of premature erosion of the insulation around some of the leads, which could cause the device to malfunction, possibly leading to inappropriate shock therapy to the heart and potentially life-threatening abnormal heart rhythms.
As of 2011, 79,000 Riata leads remained implanted in patients.
In a statement, St. Jude said, "We understand the FDA's decision to recommend fluoroscopic or X-ray screening of all patients with a Riata lead, in order to establish a baseline of understanding about the incidence rate of externalized conductors."
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement that the majority of Riata leads "continue to function normally and provide life-saving support for patients.
"However," he said, "the agency does not have enough information to determine the frequency and timing of insulation failure in these leads."
