—#91911

Product

Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490. 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: 9677978 9782770 9815916 9818226 11114442 11136721 11293746 11363706 11363710 11446486 11446487 11469423 11469424 11505595 11533039 11533260 11609089 11609091 11641656 11641657 11719767 11719779 11724859 11775292 11810807 11810808 11826778 11827140 11844030 11902674 11976448 11976450 11983554 11983581 12032282 12032283 12104904 12104909 12165663 12202729 12240622 12240624 12268113 12268117 12347713 12358111 12389244 12411182 12493383 12549443 12569914 12625606 12641424 12651730 12670352 12745821 12836479 12861706 12928786 13020239 13023144 13025849 13103653 13128160 13241825

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 #91911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.