—#91888

Product

Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. 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: 9790074 9790076 11003371 11003538 11059367 11118676 11118678 11187506 11187507 11242343 11242356 11270352 11296916 11296917 11377103 11377104 11433735 11434016 11470448 11487990 11488029 11514456 11514458 11554796 11554991 11610744 11639021 11639030 11677818 11678048 11757152 11757154 11793164 11793166 11837438 11837483 11876610 11876622 11979808 11979811 12025013 12025143 12054670 12054671 12066948 12066951 12092005 12147149 12147208 12163806 12163809 12184724 12184725 12185876 12185878 12269162 12269163 12277634 12277635 12545679 12600436 12621164 12702786 12723775 12740615 12830189 12935877 13165824 13187801 13207649 13230712

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 #91888. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.