—#91891

Product

Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. 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: 9719329 9719476 9729181 9747916 9747921 9785574 9785747 11006481 11006663 11042916 11043090 11074295 11074881 11115970 11115971 11160469 11180422 11217496 11217564 11235362 11251397 11251560 11258555 11258557 11275758 11275941 11318345 11318350 11498129 11498131 11565628 11588877 11613354 11613355 11645064 11645070 11729278 11729991 11730401 11744479 11744701 11748621 11748625 11782235 11782320 11804654 11823976 11823977 11828579 11828765 11846774 11846775 11865642 11865645 11901264 11957879 11957942 11958712 11959235 11968138 11968608 11992410 12017068 12107569 12107576 12119779 12120061 12140337 12140501 12159709 12159711 12234169 12234170 12244050 12244051 12250400 12250404 12310678 12320289 12352241 12376738 12393799 12412806 12450877 12496948 12510971 12535301 12598614 12601477 12615078 12651492 12676873 12696897 12755536 12779717 12832673 12843633 12862111 12871361 12901537 12927773 12931867 12982299 13005936 13052037 13065350 13071860 13121813 13131549 13183683 13190261 13263228 13313935 13318995

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 #91891. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.