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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/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact United States Technical Services
800-227-3422
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
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