Cl II SQ-RX 1010 Pulse Generator

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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