—#91908

Product

Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430. 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: 9712531 9762941 9786756 9786758 11001359 11001979 11043683 11043800 11078393 11079920 11101039 11156231 11156290 11165772 11165862 11385291 11416306 11416308 11466396 11486463 11486464 11536291 11536292 11543527 11543747 11572672 11573001 11592360 11612611 11612614 11700873 11700879 11736859 11749903 11749912 11785565 11819200 11819204 11827491 11827975 11843616 11843618 11895264 11906873 11906878 11907383 11907795 11992543 11992544 11997778 11999498 12032294 12032295 12111093 12111094 12133077 12133261 12133498 12159529 12159531 12169410 12227755 12227940 12291519 12291601 12316960 12321582 12351310 12354222 12379103 12410878 12458771 12459865 12493388 12519286 12568893 12605103 12617988 12635145 12674723 12732191 12776336 12887585 12905643 13006251 13064436 13071724 13098533 13121663 13177437 13187570 13188674 13221382

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 #91908. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.