BEUDAMED
    FDA Enforcement Class II Terminated

    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.

    Recall: Z-0154-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0154-2014
    Event ID
    66532
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Vascular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    October 7, 2013
    Classification Date
    November 5, 2013
    Termination Date
    February 11, 2014
    Address
    3576 Unocal Pl, N/A, Santa Rosa, CA, 95403-1774, United States

    Description

    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.

    Reason

    A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.

    Code Info

    Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.

    Distribution

    Nationwide Distribution.

    Quantity

    201 units