—#91897

Product

Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230. 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: 9693597 9707156 9707160 9747573 9814658 11004430 11084430 11084929 11198518 11205517 11205646 11414976 11414978 11426316 11427030 11525747 11582705 11582707 11625818 11742318 11754655 11783903 11783916 11801818 11863663 11863665 11929648 11929649 11984064 11984067 12027354 12027359 12028637 12072106 12072107 12124357 12124358 12126012 12165276 12165660 12251056 12338598 12342299 12410559 12465391 12530170 12581224 12603074 12614784 12639041 12720461 12721047 12829960 12836461 12881567 12978472 12987063 12989502 13173448 13184243 13196679 13203253 13235388

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 #91897. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.