BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

    Recall: Z-0938-2017 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0938-2017
    Event ID
    75813
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 11, 2017
    Initiation Date
    November 30, 2016
    Classification Date
    December 30, 2016
    Termination Date
    December 13, 2017
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

    Reason

    Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.

    Code Info

    Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.

    Distribution

    Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.

    Quantity

    15 (2 US; 13 OUS)