Class 2 Device Recall SQRX Model 1010 Subcutaneous Pulse Generator

• Date Initiated by Firm: September 17, 2015
• Date Posted: November 06, 2015
• Recall Status: Terminated on March 08, 2016
• Recall Number: Z-0232-2016
• Recall Event ID: 72225
• PMA Number: P110042
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
• Code Information: A019995 A020132 A020240
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: Boston Scientific Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte
• FDA Determined Cause: Process design
• Action: One consignee was contacted via a Boston Scientific "Medical Device Retrieval" letter dated September 17, 2015. The letter was addressed to Hospital Administrator. The letter described the problem and the product involved in the recall. Informed consignee that their local Boston Scientific sales representative will be retrieving the product form their inventory. For questions they can contact their local sales representative or Boston Scientific Technical service at 1-800-227-3422. A second Boston Scientific "Important Medical Device Information" letter dated October 2015 was hand delivered to physicians starting on 10/15/2015. The letter described the problem and provided information on Clinical Considerations, Affected Population, Recommendations and Further Information. For questions they can contact their Boston scientific representative or the Americas Technical service at 1-800-227-3422.
• Quantity in Commerce: 3
• Distribution: Distributed in the US to MA and PR.
• 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