—#91895

Product

Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. 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: Catalog Numbers: 9663612 9693003 9693004 9708705 9709379 9763608 9763610 9828124 9828280 11027105 11027229 11053709 11076452 11151542 11171283 11171287 11199522 11203740 11203744 11261000 11261458 11281926 11282276 11539261 11540270 11582708 11582709 11643976 11644160 11688258 11688640 11698615 11698685 11724216 11724217 11772331 11772332 11821584 11821588 11860799 12002002 12002178 12013093 12013094 12018679 12019188 12082197 12082420 12129860 12129863 12169049 12169051 12181375 12181395 12229947 12229950 12293029 12293033 12298605 12298607 12317788 12368065 12388264 12430522 12490847 12495053 12568403 12606620 12624516 12644379 12732528 12754940 12759600 12830237 12896795 12930767 13015806 3019421 13075118 13110000 13125440 13232453 13237201

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 #91895. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.