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
- Recall Number
- Z-3037-2017
- Event Number
- 77803
- Firm
- Boston Scientific Corporation
- FEI Number
- 2124215
- Product Code
- LWS
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 29, 2017
- Posted
- August 16, 2017
- Terminated
- February 21, 2019
- Address
- 4100 Hamline Ave N, Saint Paul, MN, 55112-5700
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.
The device can deliver an atypical amount of energy due to memory corruption inside the device.
The firm issued notifications dated June, 2017, beginning 6/29/2017 to physicians (implanting and patient follow-up physicians) via hand delivery by their sales representatives. The firm estimated approximately 30% of the U.S. physicians would be receiving the notification via hand delivery. Hand delivery by affiliates in foreign countries to customers began approximately 6/30/2017. Overnight mail letters were issued to the U.S. and foreign physicians starting on/about 7/7/2017 who did not receive hand- delivered notifications.
Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Approximately 16,750 devices