Recalls / —
—#91896
Product
Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. 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: 9657941 9658105 9696978 9737028 9822915 9822918 11084897 11143496 11150354 11150355 11252315 11253322 11485085 11485088 11540266 11540268 11603795 11605485 11640294 11640296 11716316 11723616 11775490 11808563 11808564 11871267 11871268 12026243 12026244 12049248 12049249 12107672 12150138 12150139 12206312 12206316 12239697 12239880 12271577 12271579 12407609 12441821 12494755 12518886 12570571 12601507 12604799 12621237 12645436 12697020 12889006 12957090 12986896 13116725
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 #91896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.