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U.S. Department of Health and Human Services

Class 2 Device Recall WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

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  Class 2 Device Recall WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM see related information
Date Initiated by Firm May 25, 2011
Date Posted July 15, 2011
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-2833-2011
Recall Event ID 59096
510(K)Number k000001  k003100  k021901  
Product Classification Prosthesis, tracheal, expandable - Product Code JCT
Product 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
Code Information 12163122 13051650 11843015 11877726 11891215 12015864 12130619 12203367 12270285 12392970 12763875 12935668 13374847 13446052 11789002 11813611 11877727 11891216 11949872 11960304 12016218 12149198 12270299 12330523 12392554 12440086 12745859 12954078 12990115 13022499 13052181 13326604 13346947 13442577 13474161 13552195 11877728 11949871 12148945 12408920 12776790 12917455 13171193 13552192 11721572 11749972 11788444 11810977 11855113 11960379 11978805 12427701 12609507 12848831 13041689 13171349 13223207 13538356 11788242 11789052 11811055 11855409 11960500 12240645 12303331 12370405 12427643 12613247 12695603 12834730 12936394 13092651 13348789 13446363 13553108 11721299 11788440 11811059 11880270 12131369 12586147 12586149 13376437 13552576 11721767 11734630 11789125 11813605 11857962 11880772 11891214 11981565 12092352 12428172 12442189 12610027 12745745 12918373 13052198 13148435 13422075 13474516 11788799 11813606 11880774 11949394 12036262 12050279 12073185 12073393 12112016 13041924 13113524 13498999 11785896 12035928 13297157 11844010 11981286 12269789 12933585 11959765 12016300 12609761 12935661 12989248 12348043 13132239 11844255 12131365 13051634 13221100 11960301 12333532 12395009 13490725 11931867 12269967 12439944 13487519 11959867 12395213 11858302 12167937 12183749 12185754 11721370 11785754 11843576 11858411 11960124 12035372 12080807 12112226 12745175 12933383 13236379 13445884 13490693 11844009 11858600 11891942 11979064 12131367 12201688 12348054 12408584 12694908 12847111 12986579 13168874 13376434 13411914 13422079 13490992 11858609 12016308 12333655 12637421 13020254 13422120 11878115 12203372 11719256 11877729 12204018 12427148 13115481 11787917 11843018 11891826 12270292 13051998 11858619 11960305 13494580 13498425 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact
763-494-1700
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 23,218 FOR ALL PRODUCTS
Distribution Worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JCT and Original Applicant = BOSTON SCIENTIFIC CORP.
510(K)s with Product Code = JCT and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.
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