BEUDAMED
    FDA Recall Terminated

    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.

    Recall: Z-0969-2014 · Initiated February 4, 2014

    Recall

    Recall Number
    Z-0969-2014
    Event Number
    67437
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 4, 2014
    Posted
    February 11, 2014
    Terminated
    August 4, 2014
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.

    Reason

    Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T

    Action

    Consignees were sent a Boston Scientific " Urgent Medical Device Recall Removal" letter on 2/4/2014. The letter was addressed to Materials Manager and Field Action Contact. The letter described the product involved in the recall and the problem. Advised consignees to segregate the affected lots and return to Boston Scientific in accordance to the enclosed recall instructions. The instructions also requested consignees to complete and return the Account Reply Verification Tracking Form (RVTF).

    Distribution

    US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.

    Quantity

    35 for both products.