—#91984

Product

Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560. 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: 9816069 9817313 11036675 11036678 11144629 11144633 11166987 11166989 11216390 11216391 11323985 11396170 11445664 11482673 11482674 11573664 11587624 11587625 11632696 11632698 11684142 11729256 11729291 11758555 11758559 11800671 11857948 11857950 11864916 11864981 11924090 11924160 11981528 12063950 12063951 12095744 12189616 12219705 12219708 12222329 12300932 12300934 12323321 12372682 12422996 12493176 12533397 12607272 12616628 12672122 12723732 12852679 12951197 12974865 13125446 13191733 13197059

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 #91984. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.