Recalls / —
—#91894
Product
Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070. 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: 9752358 11001400 11001402 11057106 11057486 11133494 11134003 11206281 11206282 11261393 11261396 11337238 11337381 11444217 11444219 11499381 11499399 11543942 11543945 11592688 11592689 11664729 11664734 11688255 11688256 11724218 11724381 11794682 11794685 11845373 11845374 11914027 11914032 11979190 11979425 12034909 12034910 12122990 12173686 12173687 12185338 12185339 12314457 12396282 12535625 12586819 12635961 12706496 12749115 12833386 12882124 12937032 13056438 13084405 13198350
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 #91894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.