BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

    Recall: Z-0232-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0232-2016
    Event ID
    72225
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    September 17, 2015
    Classification Date
    November 6, 2015
    Termination Date
    March 8, 2016
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

    Reason

    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

    Code Info

    A019995 A020132 A020240

    Distribution

    Distributed in the US to MA and PR.

    Quantity

    3