BEUDAMED
    FDA Recall Terminated

    Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. The WALLGRAFT Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Material Catalog # Description M001705020 70-502 WALLGRAFT PKG T/B/10X20 10FR COMML M001705030 70-503 WALLGRAFT PKG T/B/10X30 10FR COMML M001705050 70-505 WALLGRAFT PKG T/B/10X50 10FR COMML M001705070 70-507 WALLGRAFT PKG T/B/10X70 10FR COMML M001705230 70-523 WALLGRAFT PKG T/B/12X30 11FR COMML M001705250 70-525 WALLGRAFT PKG T/B/12X50 11FR COMML M001705270 70-527 WALLGRAFT PKG T/B/12X70 11FR COMML M001705450 70-545 WALLGRAFT PKG T/B 14X50 12 FR M001705470 70-547 WALLGRAFT PKG T/B 14X70 12FR M001705620 70-562 WALLGRAFT PKG T/B/6X20 9FR COMML M001705630 70-563 WALLGRAFT PKG T/B/6X30 9FR COMML M001705650 70-565 WALLGRAFT PKG T/B/6X50 9FR COMML M001705670 70-567 WALLGRAFT PKG T/B/6X70 9FR COMML M001705720 70-572 WALLGRAFT PKG T/B/7X20 9FR COMML M001705730 70-573 WALLGRAFT PKG T/B/7X30 9FR COMML M001705750 70-575 WALLGRAFT PKG T/B/7X50 9FR COMML M001705770 70-577 WALLGRAFT PKG T/B/7X70 9FR COMML M001705820 70-582 WALLGRAFT PKG T/B/8X20 9FR COMML M001705830 70-583 WALLGRAFT PKG T/B/8X30 9FR COMML M001705850 70-585 WALLGRAFT PKG T/B/8X50 9FR COMML M001705870 70-587 WALLGRAFT PKG T/B/8X70 9FR COMML M001705920 70-592 WALLGRAFT PKG T/B/9X20 10FR COMML M001705930 70-593 WALLGRAFT PKG T/B/9X30 10FR COMML M001705950 70-595 WALLGRAFT PKG T/B/9X50 10FR COMML M001705970 70-597 WALLGRAFT PKG T/B/9X70 10FR COMML

    Recall: Z-2833-2011 · Initiated May 25, 2011

    Recall

    Recall Number
    Z-2833-2011
    Event Number
    59096
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    JCT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 25, 2011
    Posted
    July 15, 2011
    Terminated
    August 10, 2012
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. The WALLGRAFT Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. Material Catalog # Description M001705020 70-502 WALLGRAFT PKG T/B/10X20 10FR COMML M001705030 70-503 WALLGRAFT PKG T/B/10X30 10FR COMML M001705050 70-505 WALLGRAFT PKG T/B/10X50 10FR COMML M001705070 70-507 WALLGRAFT PKG T/B/10X70 10FR COMML M001705230 70-523 WALLGRAFT PKG T/B/12X30 11FR COMML M001705250 70-525 WALLGRAFT PKG T/B/12X50 11FR COMML M001705270 70-527 WALLGRAFT PKG T/B/12X70 11FR COMML M001705450 70-545 WALLGRAFT PKG T/B 14X50 12 FR M001705470 70-547 WALLGRAFT PKG T/B 14X70 12FR M001705620 70-562 WALLGRAFT PKG T/B/6X20 9FR COMML M001705630 70-563 WALLGRAFT PKG T/B/6X30 9FR COMML M001705650 70-565 WALLGRAFT PKG T/B/6X50 9FR COMML M001705670 70-567 WALLGRAFT PKG T/B/6X70 9FR COMML M001705720 70-572 WALLGRAFT PKG T/B/7X20 9FR COMML M001705730 70-573 WALLGRAFT PKG T/B/7X30 9FR COMML M001705750 70-575 WALLGRAFT PKG T/B/7X50 9FR COMML M001705770 70-577 WALLGRAFT PKG T/B/7X70 9FR COMML M001705820 70-582 WALLGRAFT PKG T/B/8X20 9FR COMML M001705830 70-583 WALLGRAFT PKG T/B/8X30 9FR COMML M001705850 70-585 WALLGRAFT PKG T/B/8X50 9FR COMML M001705870 70-587 WALLGRAFT PKG T/B/8X70 9FR COMML M001705920 70-592 WALLGRAFT PKG T/B/9X20 10FR COMML M001705930 70-593 WALLGRAFT PKG T/B/9X30 10FR COMML M001705950 70-595 WALLGRAFT PKG T/B/9X50 10FR COMML M001705970 70-597 WALLGRAFT PKG T/B/9X70 10FR COMML

    Reason

    Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheobronchial strictures.

    Action

    The firm, Boston Scientific, sent an "Urgent Medical Device Field Correction" letter dated May 25, 2011 to its customers. The letter described the product, the problem and actions to be taken. The letter states that no product is being recalled and asks consignees not to return the product. The customers were instructed to read the enclosed information and post it in a way to ensure it is easily accessible to all users of this device; complete and return the Reply Verification Tracking Form via fax to: CV Field Action Center, 1-866-213-1806, and if they are a distributors to forward this notification to their customers. If you have any questions or would like assistance with this field correction, please contact your local Sales Representative and/or call 763-494-1133.

    Distribution

    Worldwide distribution.

    Quantity

    23,218 FOR ALL PRODUCTS