BEUDAMED
    FDA Enforcement Class II Terminated

    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.

    Recall: Z-1284-2015 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1284-2015
    Event ID
    70490
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 25, 2015
    Initiation Date
    November 25, 2014
    Classification Date
    March 17, 2015
    Termination Date
    May 6, 2015
    Address
    1 Saint Jude Medical Dr, Saint Paul, MN, 55117-1789, United States

    Description

    TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible radiofrequency generator and three-dimensional mapping system.

    Reason

    A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.

    Code Info

    30078, 30118, 30368, 30059, 30098, 30169, 30110, 30042, 30108, 30066, 30067, 30117, 30172, 30063, 30061, 30060, 30161, 30183, 30129, 30097, 30341, 30043, 30344, 30139, 30112, 30148, 30071, 30096, 30221, 30178, 30204, 30076, 30332, 30343, 30056, 30082, 30123, 30091, 30054, 30087, 30218, 30173, 30143, 30095, 30157, 30176, 30068, 30152, 30158, 30080, 30083, 30153, 30093, 30452, 30121, 30160, 30165, 30088, 30180, 30195, 40000, 30109, 30090, 30147, 30156, 30174, 30124, 30058, 30105, 30070, 30170, 30084, 30333, 30089, 30350, 30222, 30228, 30229, 30134, 30045, 30346, 30177, 30184, 30454, 30111, 30075, 30073, 30219, 30085.

    Distribution

    US Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, FL, GA, ID, IL IN, KS, LA, MD, MA, MI, MN,MS, NE, NV,NH, NM, NY, NC, OH, OK OR, PA, TN, TX, UT, VA,WA.

    Quantity

    89