St. Jude Medical

US FDA warns Abbott Labs over heart device problems

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The U.S. Food and Drug Administration issued a warning letter to Abbott Laboratories, citing manufacturing flaws with a range of cardiovascular devices acquired with its purchase of St. Jude Medical in January for $25 billion. The letter, dated April 12 and made public, sent Abbott’s shares down 2 percent to $42.61. The FDA, which said the company failed to disclose at least one death associated with one of the devices, said an inspection of the company’s facility in Sylmar, California, raised.

US FDA warns Abbott Labs over heart device problems

Read more at Medical Dialogues: US FDA warns Abbott Labs over heart device problems http://business.medicaldialogues.in/us-fda-warns-abbott-labs-over-heart-device-problems/

St. Jude’s Riata Defibrillator Leads Again Under the Spotlight .

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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