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U.S. Department of Health and Human Services

Class 2 Device Recall EMBLEM SICD, Model A209,

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  Class 2 Device Recall EMBLEM SICD, Model A209, see related information
Date Initiated by Firm June 29, 2017
Date Posted August 16, 2017
Recall Status1 Terminated 3 on February 21, 2019
Recall Number Z-3037-2017
Recall Event ID 77803
PMA Number P110042 
Product Classification Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
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.
Code Information All serial numbers
Recalling Firm/
Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
Manufacturer Reason
for Recall
The device can deliver an atypical amount of energy due to memory corruption inside the device.
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce Approximately 16,750 devices
Distribution Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC CORPORATION