[1] FDA Safety Communication: "Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc. (Sept. 24, 2013).
Following mounting evidence that their Riata leads were prone to premature erosion of the insulation around the electrical conductor wires, in 2011 St. Jude Medical recalled the implantable cardiac defibrillator (ICD) leads. St. Jude stopped selling the Riata leads in late 2010, but more than 227,000 of the leads were distributed and thousands remain implanted in patients worldwide. Insulation failure may cause some of the electrical conductors inside Riata leads to malfunction. Malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shocks, which could result in serious adverse events, including death. St. Jude has now introduced two newer lead products, the Riata ST Optim and Durata, that it claims are free of the problems that plagued the Riata model.
[1] FDA Safety Communication: "Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc. (Sept. 24, 2013).
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