BEUDAMED
    FDA Recall 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 · Initiated September 29, 2016

    Recall

    Recall Number
    Z-0328-2017
    Event Number
    75395
    Firm
    SentreHeart Inc
    FEI Number
    3006482885
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 29, 2016
    Posted
    November 9, 2016
    Terminated
    March 1, 2017
    Address
    300 Saginaw Dr, Redwood City, CA, 94063-4743

    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.

    Action

    SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to [email protected]. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008.

    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