Recall Z-2832-2011 ยท JCT Prosthesis, Tracheal, Expandable
Boston Scientific Corporation
Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. Indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms. WALLSTENT" Endoprosthesis Material Catalog # Description H965402100 40210 12X20/8FR UNI
| Date | Jul 15, 2011 (initiated May 25, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| 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 notif |
| Quantity | 23,218 TOTAL FOR ALL PRODUCTS |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943116 | AUTO SUTURE KERRISON SPINAL RONGEUR United States Surgical, A Division of Tyco Healthc, Jul 27, 1994 |
| K945494 | WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc., Mar 3, 1995 |
| K961296 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc., Jul 10, 1996 |
| K964121 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc., Dec 4, 1996 |
| K980163 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING Boston Scientific Scimed, Inc., Mar 13, 1998 |