BEUDAMED
    FDA Enforcement Class II Terminated

    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

    Recall: Z-2738-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2738-2016
    Event ID
    73833
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2016
    Initiation Date
    March 16, 2016
    Classification Date
    September 6, 2016
    Termination Date
    January 27, 2017
    Address
    950 Elkton Blvd, Elkton, MD, 21921-5322, United States

    Description

    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath

    Reason

    Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. If affected introducer sheaths are used, there is possible risk of incremental blood loss through the valve.

    Code Info

    Please see Attachment 3

    Distribution

    Nationwide Distribution

    Quantity

    1,370,995 eaches have been distributed to the field