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Terminated

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 PLUS HALO 100CM H965402110 40211 12X40/8FR UNI PLUS HALO 100CM H965402120 40212 12X60/8FR UNI PLUS HALO 100CM H965402130 40213 12X90/8FR UNI PLUS HALO 100CM H965403100 40310 14X20/9FR UNI PLUS HALO 100CM H965403110 40311 14X40/9FR UNI PLUS 100CM H965403120 40312 14X60/9FR UNI PLUS 100CM H965403130 40313 14X90/9FR UNI PLUS 100CM H965403300 40330 16X20/9FR UNI PLUS 100CM H965403310 40331 16X40/9FR UNI PLUS 100CM H965403320 40332 16X60/9FR UNI PLUS 100CM H965403330 40333 16X90/9FR UNI PLUS 100CM H965404110 40411 18X40/10FR UNI PLUS 100CM H965404120 40412 18X60/10FR UNI PLUS 100CM H965404130 40413 18X90/10FR UNI PLUS 100CM H965404300 40430 20X40/10FR UNI PLUS 100CM H965404310 40431 20X55/10FR UNI PLUS 100CM H965404320 40432 20X80/10FR UNI PLUS 100CM H965404500 40450 22X35/10FR UNI PLUS 100CM H965404510 40451 22X45/10FR UNI PLUS 100CM H965404520 40452 22X70/10FR UNI PLUS 100CM H965405100 40510 24X35/11FR UNI PLUS 100CM H965405110 40511 24X45/11FR UNI PLUS 100CM H965405120 40512 24X70/11FR UNI PLUS 100CM H965412000 41200 12X20/135CM 8FR BARE UNI + HALO 160CM H965412010 41201 12X40/135CM 8FR BARE UNI + HALO 160CM H965412020 41202 12X60/135CM 8FR BARE UNI + HALO 160CM H965412030 41203 12X90/135CM 8FR BARE UNI + HALO 160CM WALLSTENT" RP Endoprosthesis Material Catalog # Description M001711000 71-100 5x20x75/ 6F Unistep Plus M001711010 71-101 5x20x135/ 6F Unistep Plus M001711020 71-102 5x40x75/ 6F Unistep Plus M001711030 71-103 5x40x135/ 6F Unistep Plus M001711040 71-104 5x55x75/ 6F Unistep Plus M001711050 71-105 5x55x135/ 6F Unistep Plus M001711060 71-106 5x80x75, 6F Unistep Plus M001711080 71-108 6x20x75/ 6F Unistep Plus M001711090 71-109 6x20x135/ 6F Unistep Plus M001711100 71-110 6x45x75/ 6F Unistep Plus M001711110 71-111 6x45x135/ 6F Unistep Plus M001711120 71-112 6x60x75/ 6F Unistep Plus M001711130 71-113 6x60x135/ 6F Unistep Plus M001711140 71-114 6x90x75/ 6F Unistep Plus M001711150 71-115 6x90x135/ 6F Unistep Plus M001711160 71-116 7x20x75/ 6F Unistep Plus M001711160 71-116 7x20x75/ 6F Unistep Plus M001711170 71-117 7x20x135/ 6F Unistep Plus M001711180 71-118 7x40x75/ 6F Unistep Plus M001711190 71-119 7x40x135/ 6F Unistep Plus M001711200 71-120 7x60x75/ 6F Unistep Plus M001711210 71-121 7x60x135/ 6F Unistep Plus M001711220 71-122 7x90x75/ 6F Unistep Plus M001711230 71-123 7x90x135/ 6F Unistep Plus M001711240 71-124 8x20x75/ 6F Unistep Plus M001711250 71-125 8x20x135/ 6F Unistep Plus M001711260 71-126 8x40x75/ 6F Unistep Plus M001711270 71-127 8x40x135/ 6F Unistep Plus M001711280 71-128 8x60x75/ 6F Unistep Plus M001711290 71-129 8x60x135/ 6F Unistep Plus M001711300 71-130 8x80x75/ 6F Unistep Plus M001711310 71-131 8x80x135/ 6F Unistep Plus M001711320 71-132 10x20x75/ 6F Unistep Plus M001711330 71-133 10x20x135/ 6F Unistep Plus M001711340 71-134 10x42x75/ 7F Unistep Plus M001711350 71-135 10x42x135/ 7F Unistep Plus M001711360 71-136 10x68x75/ 7F Unistep Plus M001711370 71-137 10x68x135/ 7F Unistep Plus M001711380 71-138 10x94x75/ 7F Unistep Plus M001711390 71-139 10x94x135/ 7F Unistep Plus

FDA Recall Z-2832-2011 · Posted 2011-07-15

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeJCT
Date Initiated2011-05-25
Date Terminated2012-08-10
Product Quantity23,218 TOTAL FOR ALL PRODUCTS

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.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980163WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERINGBoston Scientific Scimed, Inc. · 1998-03-13K964121WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESISBoston Scientific Scimed, Inc. · 1996-12-04K961296WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESISBoston Scientific Scimed, Inc. · 1996-07-10K945494WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESISBoston Scientific Scimed, Inc. · 1995-03-03K943116AUTO SUTURE KERRISON SPINAL RONGEURUnited States Surgical, A Division of Tyco Healthc · 1994-07-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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