Class 2 Device Recall Implantable Cardioverter Defibrillator (NonCRT)

• Date Initiated by Firm: November 01, 2018
• Create Date: November 16, 2018
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-0474-2019
• Recall Event ID: 81471
• PMA Number: P110042
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System; ; 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: SQ-RX Pulse Generator Model 1010
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N Bldg 3; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
• FDA Determined Cause: Device Design
• Action: The firm, Boston Scientific, sent an "Important Medical Device Information" letter to customers on November 5, 2018 by hand, email via our sales representatives or Federal Express or Courier. The letter described the product, problem and actions to be taken. We will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/product-advisories.html. The customers were instructed to do the following: Your doctor has been notified to look for this possible change, so please go to all scheduled defibrillator checks and clinic visits. As always, if you or your family hear beeping from your device, please contact your heart clinic as soon as possible. Your doctor can confirm your ability to hear and recognize this sound during an appointment. If you have additional questions regarding this information or would like to report a clinical event, please contact your Boston Scientific representative or Technical Services, or the Recall Contact at 651-582-3494 or email: Heather.Young@bsci.com.
• Quantity in Commerce: 12,900
• Distribution: US Nationwide Distribution: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming.
• 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