Recalls / —
—#91885
Product
Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. 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: 9819553 9819558 11057820 11057934 11128481 11128701 11188630 11188633 11254268 11254269 11327810 11327811 11486465 11486466 11591307 11648322 11648324 11687601 11740562 11792533 11828568 11828569 11891601 11933261 11933262 12150199 12295530 12305996 12395349 12463767 12517752 12602517 12619264 12652845 12685511 12687464 12862108 12870991 13074818 13103999 13129113 13138519 13203489
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 #91885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.