BEUDAMED
    FDA Recall 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 · Initiated October 7, 2013

    Recall

    Recall Number
    Z-0154-2014
    Event Number
    66532
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3001452571
    Product Code
    NIQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 7, 2013
    Posted
    November 5, 2013
    Terminated
    February 11, 2014
    Address
    3576 Unocal Pl, Santa Rosa, CA, 95403-1774

    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.

    Action

    Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.

    Distribution

    Nationwide Distribution.

    Quantity

    201 units