BEUDAMED
    FDA Recall Terminated

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    Recall: Z-1342-2016 · Initiated March 22, 2016

    Recall

    Recall Number
    Z-1342-2016
    Event Number
    73633
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 22, 2016
    Posted
    April 18, 2016
    Terminated
    August 11, 2017
    Address
    2 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    Reason

    Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

    Action

    The firm,Boston Scientific, "Urgent Medical Device Recall Notice - Immediate Action Required" letter dated 3/22/2016. The letter was addressed to Material Manger / Field Action Contact. The letter described the problem and the product involved in the recall and actions to be taken. The customers were instructed to immediately cease further distribution or use of the product and complete and return the Reply Verification Tracking Form via email: [email protected] or fax to: BSC Field Action Center at 1-866-213-1806. Distributors should notify their customers of the recall and inform them that this recall is to the hospital level. For questions regarding this communication, please contact your local Boston Scientific Sales Representative or the Boston Scientific Field Action Center at 763-494-1133 or email: [email protected].

    Distribution

    Worldwide Distribution - US (nationwide) including DC & VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.

    Quantity

    21,155 units