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. |
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