BEUDAMED
    FDA Enforcement Class I Completed

    SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use

    Recall: Z-2710-2019 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-2710-2019
    Event ID
    82525
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    Medtronic Vascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    March 15, 2019
    Classification Date
    September 30, 2019
    Termination Date
    April 26, 2024
    Address
    35 Cherry Hill Dr # 37a, N/A, Danvers, MA, 01923-2565, United States

    Description

    SHERPA NX ACTIVE GUIDING CATHETER, 6F M RADIAL, .070", REF SA6MRADIAL. for cardiovascular use

    Reason

    There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

    Code Info

    GTIN: 00613994823052 All Lot/Serial Numbers

    Distribution

    Worldwide distribution to US, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Italy, Kazakhstan, Luxembourg, Moldova, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Taiwan, and United Kingdom

    Quantity

    26 units