—#91985

Product

Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570. 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: 9756366 9756988 11020192 11056395 11099754 11132479 11133187 11147078 11147156 11169806 11169807 11248614 11257090 11257098 11319126 11319246 11498702 11499093 11577525 11582509 11582515 11639672 11639674 11647173 11647422 11703446 11723976 11724210 11748608 11748610 11768753 11768755 11791250 11791251 11840263 11840266 11862820 11902118 11902460 11931828 11942286 11944801 12000422 12000425 12075443 12075444 12089895 12089896 12156911 12156953 12223030 12294304 12294305 12295796 12295798 12369548 12396685 12432385 12503377 12551946 12583949 12608681 12625461 12710132 12731246 12748492 12830620 12848174 12869065 12903982 12946195 12954565 12965789 12969280 12975407 13166713 13176564 13220243 13253488

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 #91985. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.