BEUDAMED
    FDA Enforcement Class II Terminated

    Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

    Recall: Z-0852-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0852-2019
    Event ID
    81863
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    December 19, 2018
    Classification Date
    February 20, 2019
    Termination Date
    June 9, 2020
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565, United States

    Description

    Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

    Reason

    A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.

    Code Info

    Material Number (UPN) H749M3004A0, Batch Number 21558994, Expiration Date 11/30/2019

    Distribution

    Nationwide distribution to AR, CT, FL, IA, IL, IN, KY, MA, MI, ND, NJ, NY, OH, OK, PA, SC, TX, VA, WI, WY.

    Quantity

    49 units