The U.S. Food and Drug Administration (FDA) announced on Feb. 19 that Boston Scientific has issued a Class I recall of the EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) system due to risk of short circuit that may lead to injury or death.

The recall is due to a "manufacturing process [that] may allow moisture to get inside the defibrillator," the FDA said. "A defibrillator with the manufacturing error may delay or prevent the device from delivering a lifesaving electrical shock to a person in cardiac arrest (tachycardia) … Additional surgeries may also be needed to replace failed devices."

No injuries or deaths have been reported to date. Read the full FDA announcement.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ACC Advocacy, Coronavirus, Defibrillators, Implantable, United States Food and Drug Administration, Equipment Failure, Tachycardia

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