In December 2011, the Food and Drug Administration issued a Class 1 recall for the St. Jude Medical Riata leads after many adverse events were being reported in patients.
Source:
www.prnewswire.com/news-releases/torklaw-responds-to-fda-warning-letter-to-st-jude-medical-regarding-defective-heart-device-now-representing-patients-in-15-states-190500161.html
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