BEUDAMED
    FDA Recall Terminated

    Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

    Recall: Z-3043-2017 · Initiated June 15, 2017

    Recall

    Recall Number
    Z-3043-2017
    Event Number
    77820
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    MAV
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 15, 2017
    Terminated
    July 22, 2020
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

    Reason

    Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

    Action

    The firm initiated their recall on 06/15/2017 by letter delivered by Fed Ex in the US, on 06/15-29/2017 in the Americas delivered by Courier, email and hand delivery, on 06/16/2017 in Europe by DHL, on 06/16-19/2017 in the Arab Emirates and East Asia by email and hand delivery and on 06/136/2017 in Japan by hand delivery. In the notice, the firm described the problem and requested the following action: 1. Immediately check the inventory and identify whether there are products with UPNs and lot numbers affected by the recall. 2. Inspect the device tray in the area highlighted above. If any units with a cracked tray are identified in the supply, immediately discontinue use and segregate affected units in a secure location. 3. Arrange for the damaged units to be returned to Boston Scientific by completing the attached Reply Verification Tracking Form. 4. If no damage is identified, the device may be used as normal. Please complete and return the attached Reply Verification Tracking Form

    Distribution

    Worldwide

    Quantity

    305,779 units