—#91903

Product

Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. 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: 9710497 9710747 9822080 9822106 11112045 11112046 11184460 11184466 11201847 11201848 11431347 11477279 11477540 11576821 11624591 11661903 11662027 11768846 11768848 11873424 12025943 12025945 12110520 12110523 12163277 12235155 12235454 12270227 12375502 12407153 12470816 12531186 12604039 12618533 12650205 13131724 13314095

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 #91903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.