FDA-Device2017-08-23Class II
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.
Boston Scientific Corporation
Hazard
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Sold states
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Affected count
Approximately 16,750 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3037-2017Don't want to check this manually?
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