FDA Enforcement
Class II
Terminated
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: Z-3037-2017
·
Reported August 23, 2017
Enforcement
- Recall Number
- Z-3037-2017
- Event ID
- 77803
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- August 23, 2017
- Initiation Date
- June 29, 2017
- Classification Date
- August 15, 2017
- Termination Date
- February 21, 2019
- Address
- 4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States
Description
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.
Reason
The device can deliver an atypical amount of energy due to memory corruption inside the device.
Code Info
All serial numbers
Distribution
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Quantity
Approximately 16,750 devices