BEUDAMED
    FDA Enforcement Class II Terminated

    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).

    Recall: Z-0114-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0114-2017
    Event ID
    75211
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sequent Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    September 23, 2016
    Classification Date
    October 27, 2016
    Termination Date
    May 1, 2017
    Address
    11 Columbia, Aliso Viejo, CA, 92656-1460, United States

    Description

    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).

    Reason

    Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.

    Code Info

    16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701

    Distribution

    Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,

    Quantity

    618 units