Another St. Jude ICD Lead Recall, But Impact May Be Limited
This article was originally published in The Gray Sheet
The recall, related to a manufacturing misstep for St. Jude's Optisure defibrillator leads, effects 447 devices and has not been linked to any patient injuries, the firm says.
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The settlement, which does not include an admission of fault, puts an end to a long-running class action claim filed by investors who say they were misled by St. Jude’s failure to announce FDA safety concerns around the company’s Durata heart leads.
The company stresses that FDA’s letter does not identify any specific concerns about Durata or any other product, but the citation nonetheless states that the leads are “adulterated” due to quality system violations and “misbranded” due to adverse event reporting lapses.
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