Recalls / —
—#91900
Product
Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. 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: 9775346 9820252 9821003 11073086 11125407 11162573 11162577 11209018 11209603 11409760 11425714 11425716 11480359 11482285 11542522 11542525 11592820 11631290 11753170 11771715 11801806 11801807 11871828 11871829 11926337 11926338 12049734 12180770 12237417 12278108 12367211 12374936 12410617 12423649 12536705 12564510 12592185 12701997 12722753 12905184 12939325 13010286 13058269 13133434 13151193
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 #91900. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.