Company:Boston Scientific Corporation.
Date of Enforcement Report 8/23/2017
ClasslI:

PRODUCT

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

REASON
The device can deliver an atypical amount of energy due to memory corruption inside the device.

RECALLING FIRM/MANUFACTURER
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

DISTRIBUTION
Nationwide and Internationally

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