BEUDAMED
    FDA Enforcement Class II Terminated

    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.

    Recall: Z-0188-2018 · Reported December 6, 2017

    Enforcement

    Recall Number
    Z-0188-2018
    Event ID
    78570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2017
    Initiation Date
    November 3, 2017
    Classification Date
    November 29, 2017
    Termination Date
    September 1, 2020
    Address
    4600 Nathan Ln N, N/A, Plymouth, MN, 55442-2890, United States

    Description

    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.

    Reason

    Stent length on the label may not match the length of the stent itself.

    Code Info

    Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328. Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.

    Distribution

    Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA

    Quantity

    21 units