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3 years ago

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FDA labels Boston Scientific ICD electrode recall serious - MassDevice

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FDA labels Boston Scientific ICD electrode recall serious - MassDevice

The FDA today declared the recall of a Boston Scientific subcutaneous electrode used in implantable cardioverter defibrillators (ICDs) as Class 1, the most serious. The company warned physicians in December 2020 that approximately 47,000 Emblem S-ICD1 subcutaneous electrodes (model 3501) may fracture. Boston Scientific said at the time that it had received 27 reports of […]

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FDA labels Boston Scientific ICD electrode recall serious - MassDevice

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FDA labels Boston Scientific ICD electrode recall serious - MassDevice

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