FDA warns of St. Jude heart devicesby Martin Moylan, Minnesota Public Radio
ST PAUL, Minn. — Federal health officials have issued new advice for people with certain implantable devices made by St. Jude Medical.
The advice concerns Riata-brand wires, which connect defibrillators to the heart. Defibrillators deliver an electric shock to restore an erratically beating or stopped heart to a normal rhythm.
St. Jude stopped selling the connectors in 2010 amid reports bare wire was breaking through its protective insulation. The defect can lead to inappropriate shocks, as well as failure to provide a life-saving jolt of electricity when a patient's heart stops.
The FDA says patients with Riata wires should get X-rays or other imaging tests to detect potential defects. The agency says that in the vast majority of patients the connections are working and should not be removed from patients.
The FDA has also told St. Jude to conduct imaging studies on its current generation of connecting wires.