BEUDAMED
    FDA Recall Terminated

    MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr

    Recall: Z-0831-03 · Initiated April 29, 2003

    Recall

    Recall Number
    Z-0831-03
    Event Number
    26206
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 29, 2003
    Posted
    May 15, 2003
    Terminated
    March 11, 2004
    Address
    1 Boston Scientific Place, Natick, MA, 01760

    Description

    MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr

    Reason

    Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr

    Action

    The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.

    Distribution

    CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,

    Quantity

    27 units