Class 2 Device Recall RESONATE X4 CRTD

• Date Initiated by Firm: October 04, 2017
• Create Date: November 08, 2017
• Recall Status: Terminated on October 15, 2019
• Recall Number: Z-0081-2018
• Recall Event ID: 78323
• PMA Number: P010012
• Product Classification: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
• Product: RESONATE X4 CRT-D, Model G447, Sterile.
• Code Information: Serial numbers 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606
• 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: 11 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 = NIK