Patients may have concerns about their cardiac devices after reading a front-page New York Times story about St. Jude Medical‘s embattled Riata defibrillator leads. The leads were recalled in 2011 over the risk for failure associated with lead insulation abrasion.

The Times describes the dilemma now faced by cardiac device specialists and patients: take a potentially faulty lead out, or leave it in? Both strategies carry their own risks, the Times notes, although the FDA advises against preemptive lead removal. A study by the manufacturer suggests that 19% of Riata leads show signs of failing.

In August, the FDA recommended imaging studies for patients with Riata leads to check for possible failures. A specialist practicing near Chicago told the Times he was unaware of the FDA’s action until a reporter told him about it, adding that a St. Jude representative failed to mention the new guidance during a discussion late that month.

Source: New York Times