St. Jude Medical - Heart Lead Recall

Heart Lead Recall

On Nov. 28, 2011 St. Jude Medical recalled Riata and Riata ST leads due to device failure. The recall occurred because erosion of the insulation around the electrical conductor wires that connect the heart to the implantable cardioverter defibrillator.

A probe was conducted by the Food and Drug Administration (FDA) at the manufacturing plant in Sylmar, California, which could result in a warning letter.

Almost a year later in the third and fourth weeks of November 2012 the FDA found several problems in the Durata, which is the electrical wire that connects an implanted defibrillator to a patients heart. The FDA inspectors said that they found flaws in the testing process and oversight of the Durata. People have voiced their worries on the possible glitches in the Durata, and many of them are people who are very educated on the previous problems with the heart wire the Riata. One of these people is a heart specialist in Minnesota named Dr. Robert Hauser. He feels the people at St. Jude Medical have not given patients and doctors enough information, and early in 2012 he had written an article criticizing the Riata. But St. Jude Medical has stuck by their product, and claim the Durata will not be a problem like the Riata was because they used a different type of insulation.