—#91983

Product

Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.

FDA product code: JCT — Prosthesis, Tracheal, Expandable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K012883
Affected lot / code info: Lot Numbers: 9680008 9681085 9700231 9700374 9713320 9713438 9734409 9802443 9803989 9817872 9818076 11028750 11028754 11058075 11089995 11105176 11105906 11108385 11108395 11135858 11178064 11178948 11189414 11204847 11326003 11326946 11346995 11346997 11408405 11408414 11411702 11411704 11423540 11428371 11441873 11441874 11491180 11491197 11524858 11525005 11535361 11535693 11555213 11555214 11582710 11582711 11633030 11641651 11641652 11663056 11663143 11666007 11666008 11681509 11681821 11735629 11757145 11758767 11789894 11790060 11803647 11803651 11807691 11807695 11830050 11859112 11859115 11862564 11862566 11871607 11873110 11873111 11911133 11929647 11931571 11950411 11994278 11994421 12017293 12032796 12071583 12071584 12085237 12085239 12095745 12155466 12179770 12182204 12182208 12200624 12236729 12248935 12252556 12252653 12303221 12303225 12318367 12323565 12355391 12356517 12360258 12392955 12403141 12440786 12504027 12521810 12565231 12591591 12620468 12634858 12657391 12658631 12678542 12723148 12746136 12756459 12834557 12844740 12852211 12868561 12871162 12899113 12981367 13004199 13035639 13061429 13065825 13072177 13077761 13108917 13118617 13177983 13180941 13188824 13190965 13196884 13281686

Why it was recalled

Suture related device failures during deployment and repositioning of the stent

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide Distribution - Only US distributed product is affected by recall

Timeline

Recall initiated: 2010-05-17
Posted by FDA: 2010-06-25
Terminated: 2011-10-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91983. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.