Class 2 Device Recall Ultraflex tracheobronchial Stent System

• Date Initiated by Firm: May 17, 2010
• Date Posted: June 25, 2010
• Recall Status: Terminated on October 20, 2011
• Recall Number: Z-1827-2010
• Recall Event ID: 55784
• 510(K)Number: K012883
• Product Classification: Prosthesis, tracheal, expandable - Product Code JCT
• Product: Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
• Code Information: Lot Numbers: 9634841 9634845 9721675 9727354 9727372 9765848 9766323 9817320 9817497 9823497 9824440 11005050 11005053 11041572 11041573 11060439 11061476 11063331 11063374 11096068 11096073 11119006 11119173 11152523 11153335 11169338 11169594 11197217 11249077 11250366 11255391 11255392 11260093 11260352 11267520 11268170 11273309 11273315 11338177 11338360 11357474 11357581 11404600 11404603 11429217 11429701 11465855 11465859 11478134 11478135 11506003 11506008 11525146 11525151 11560635 11560741 11563824 11565626 11581527 11581529 11592362 11592363 11601963 11601964 11647778 11647839 11676517 11676740 11680039 11680220 11700034 11700221 11703828 11703830 11750111 11750113 11771497 11771664 11774304 11774308 11774845 11787063 11787064 11814052 11814054 11847077 11847078 11847079 11847100 11847101 11847102 11875440 11875445 11877337 11877339 11888467 11888470 11924826 11924839 11925156 11925324 11934143 11934144 12001530 12001748 12002494 12002820 12008477 12013635 12013636 12014267 12014268 12033293 12033298 12120841 12120848 12125328 12125523 12148793 12149185 12199930 12200253 12219246 12219250 12225782 12225783 12238688 12238689 12298022 12298031 12303604 12316035 12333642 12374153 12384435 12397962 12403279 12421962 12445505 12479777 12514709 12529441 12565953 12571272 12605210 12624519 12632783 12639187 12655072 12675646 12685515 12727552 12739070 12742771 12776530 12829072 12833391 12836271 12860941 12880204 12895590 12916220 12935597 12976131 12989433 12992137 12992930 13022704 13047831 13051711 13058915 13072983 13141887 13148451 13149042 13149052 13180609 13182177 13183332 13185668 13248151 13253753
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: same; 508-683-8000
• Manufacturer Reason for Recall: Suture related device failures during deployment and repositioning of the stent
• FDA Determined Cause: Device Design
• Action: Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.
• Distribution: Worldwide Distribution - Only US distributed product is affected by recall
• 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