—#91989

Product

Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. 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: 9649130 9649131 9818579 9818588 11107095 11170337 11170339 11222550 11397903 11448934 11513546 11555992 11595776 11704469 11759267 11759268 11794636 11794637 11809672 11809674 11847114 11877066 11877068 12029553 12029554 12074329 12074333 12088528 12088533 12216682 12266301 12266303 12412119 12551613 12572893 12616327 12639913 12744882 12745231 12834879 12862472 12881353 13016204 13055063 13086404 13176861 13282672 13284402

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 #91989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.