Company:Boston Scientific Corporation.
Date of Enforcement Report 8/23/2017
EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
Recall Number Z-3039-2017
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Boston Scientific Corporation, Saint Paul, MN on 6/29/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Approximately 12,450 devices
Nationwide and Internationally