Class 2 Device Recall RESONATE EL ICD DR

• Date Initiated by Firm: October 04, 2017
• Create Date: November 08, 2017
• Recall Status: Terminated on October 15, 2019
• Recall Number: Z-0078-2018
• Recall Event ID: 78323
• PMA Number: P960040
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: RESONATE EL ICD DR, Model D433, Sterile.
• Code Information: Serial numbers 530802, 531123, 531237, 531292, 531301, 531446, 531492, 531520, 531536, 531539, 531545, and 531767.
• 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 devices have an incorrect firmware configuration.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated October 2017 on 10/4/2017 via delivery by the sales representative.
• Quantity in Commerce: 12 devices
• Distribution: The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.
• 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