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Boston Scientific Corporation recalls EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD sy
Recalled August 23, 2017 · FDA recall Z-3038-2017 · Boston Scientific
Hazard
The device can deliver an atypical amount of energy due to memory corruption inside the device. · FDA Class II
Units
Approximately 9,200 devices
Sold at
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Description
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Product
EMBLEM MRI S-ICD Model 219, 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
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →