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St. Jude Recalls System to Help Hole-in-Heart Therapy

St. Jude Medical Inc. recalled a new delivery system used to treat people with a dangerous hole in the heart after discovering the device could fracture in a small number of cases, U.S. regulators said.

The core wire in the Amplatzer TorqVue FX Delivery System may fracture, causing serious damage and perhaps death, the Food and Drug Administration said today in a notice on its website. The Class 1 recall, considered the most serious type, was initiated on Jan. 18, the agency said.