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Highlights the failure of postmarketing device surveillance in the U.S., exemplified by the recall of Riata and Riata ST ICD leads.
U.S. patients continue to be exposed to underperforming and potentially hazardous medical devices after FDA approval. Most recently, Riata and Riata ST implantable cardioverter–defibrillator leads — currently implanted in more than 75,000 U.S. patients — were recalled.
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Robert G. Hauser (2012) studied this question.
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