BEUDAMED
    FDA Enforcement Class I Terminated

    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.

    Recall: Z-0328-2017 · Reported November 16, 2016

    Enforcement

    Recall Number
    Z-0328-2017
    Event ID
    75395
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    SentreHeart Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 16, 2016
    Initiation Date
    September 29, 2016
    Classification Date
    November 9, 2016
    Termination Date
    March 1, 2017
    Address
    300 Saginaw Dr, Redwood City, CA, 94063-4743, United States

    Description

    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.

    Reason

    A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.

    Code Info

    Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150

    Distribution

    Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany

    Quantity

    132 worldwide distribution (98) of those units in US