The Food and Drug Administration ordered St. Jude Medical on Thursday to conduct additional studies on patients implanted with heart-device components that were recalled last year and that have been linked to as many as 20 deaths. It also recommended that patients receive X-rays or other imaging to check for problems with their devices.
The Riata lead, which St. Jude stopped selling in 2010, is a wire that connects a defibrillator to a patient’s heart. Internal wires in the lead have been shown to break through the protective outer coating and cause unintended shocks in some patients. Defective leads may also prevent the defibrillator from working when needed by the patient. Defibrillators deliver a jolt of electricity to interrupt a potentially fatal heart rhythm.
Problems with the Riata leads have dogged the company since late last year. It sent an alert to doctors at that time about the exposed wires and said it would study the issue. Since then, doctors have scrambled to understand the scope of the problem and how best to address failing leads in patients, because removal of the components can also be dangerous. In March, a prominent researcher published a study claiming the Riata lead played a role in some 20 deaths, a contention the company disputed.
About 128,000 patients worldwide still use the Riata lead, according to the company.
On Thursday, the F.D.A. recommended that patients’ doctors check for abnormalities in the insulation around the leads, noting that previous studies showed that X-rays and other imaging had uncovered problems. But it cautioned against routinely removing the leads, a warning that St. Jude underscored on Thursday.
“It is important to note that in published studies, the majority of leads with externalized conductors have continued to function properly,” the company said in a statement. It said that it would continue to work with the F.D.A. “to understand the ongoing performance of our leads and whether additional studies need to be initiated.”
Based on its own study, St. Jude last month reported initial findings, saying abnormalities had been found in 9.3 percent of the patients with one Riata model and in 24 percent of patients with another. The agency ordered the company to answer questions about how quickly the leads failed after implantation and to report on injuries or deaths related to the malfunctions.
It also called for studies of other types of leads, including a new model called the Durata that the company has said does not have the same problem.
St. Jude’s stock dropped after the F.D.A.’s recommendations became public Thursday afternoon and closed down more than 4 percent.
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