Date Initiated by Firm |
June 29, 2017 |
Date Posted |
August 16, 2017 |
Recall Status1 |
Terminated 3 on February 21, 2019 |
Recall Number |
Z-3039-2017 |
Recall Event ID |
77803 |
PMA Number |
P110042 |
Product Classification |
Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
|
Product |
SQ-RX 1010 Pulse Generator, 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 12,450 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
|