—#91982

Product

Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. 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: 9681425 9702667 9702668 9717705 9805013 9805176 9826460 9826461 11043810 11044745 11079254 11079255 11115641 11115646 11127080 11127082 11148822 11148823 11172971 11173298 11201028 11201034 11262987 11263514 11459616 11459617 11481585 11481640 11518709 11533436 11533880 11584312 11584453 11603850 11603853 11633581 11633583 11669424 11669428 11684387 11684393 11739270 11769537 11769538 1179911211799114 11837690 11847111 11847112 11875168 11875169 11912282 11912363 11949659 11949878 11997274 11999499 12030707 12031033 12068405 12068412 12127111 12127202 12155219 12155460 12161853 12161858 12168047 12170976 12171120 12189009 12236551 12236553 12252017 12256858 12256859 12273744 12273745 12286484 12286486 12375402 12408323 12433248 12444657 12515840 12550410 12581110 12632664 12644160 12687082 12748618 12765279 12845905 12862780 12865729 12915206 12950476 12964896 12969284 12972706 13075787 13106646 13173446 13176567 13193882 13242715 13262862 13264738

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 #91982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.