—#91904

Product

Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. 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: 9828690 9828691 11084898 11084899 11207573 11207575 11503181 11503182 11631699 11631921 11710669 11710670 11750563 11750569 11807425 11877662 11957664 11957676 11977820 11977826 12105341 12105346 12297199 12297365 12305456 12305800 12411409 12482912 12485984 12591205 12624300 12650674 12836583 13168173 13200037

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 #91904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.