Boston Scientific, WALLGRAFT OVER-THE-WIRE, Tracheobronchial Endoprosthesis, Made in IRELAND, Ballybrit Business Park, G

FDA device recall Z-2833-2011 · posted 2011-07-15 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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 taken

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.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

JCT

Quantity affected

23,218 FOR ALL PRODUCTS

Distribution

Worldwide distribution.

Date initiated

2011-05-25

Date posted

2011-07-15

Date terminated

2012-08-10

Location

Maple Grove, MN

Related 510(k) clearances