Friday, February 19, 2021

Boston Scientific Recalls EMBLEM S-ICD System

Learn more about Boston Scientific's Recall of the EMBLEM S-ICD System

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US Food and Drug Administration

Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit

Boston Scientific is recalling the EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) system because a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high voltage shocks. If this happens during use, this may lead to serious adverse events, including injury or death.

The FDA has identified this as a Class I recall, the most serious type of recall.

Read the Recall Notice


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