U.K. urges docs to monitor St. Jude's recalled Riata leads

Mon, 09/17/2012 - 3:42pm
Mass Device

U.K. regulators warn physicians to remain vigilant in monitoring patients implanted with St. Jude Medical's recalled Riata and Riata ST silicone-coated pacemaker wires.

St. Jude Medical logo

U.K. regulators issued new updates to physicians handling patients implanted with St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator wires, urging continued monitoring for failures that may prompt replacement.

The country's Medicines & Healthcare products Regulatory Agency asked clinics to check on patients every 3 months to look for varying signs of failure and conduct lead integrity testing.

The agency warned against replacing intact devices, which involves an invasive and potentially dangerous surgery, except in "exceptional clinical circumstances."


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