Recalls / —
—#91998
Product
Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number M00513710. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Intended for maintaining esophageal luminal patency in esophageal structures caused by intrinsic and/or extrinsic malignant tumors only and occlusion of concurrent esophageal fistulas.
- FDA product code
- ESW — Prosthesis, Esophageal
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K032930
- Affected lot / code info
- Lot Number: 11724999 11750562 11772144 11789124 11804527 11805916 11814267 11828772 11838215 11842853 11869860 11871017 11890226 11895585 11910600 11938641 11946094 11960111 11991499 12010105 12106264 12112949 12124527 12167829 12201387 12238992 12249808 12271795 12304585 12319567 12354941 12439846 12464020 12480567 12510365 12547605 12581227 12604481 12686690 12745544 12860643 12885056 12900596 12915092 12932252
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 #91998. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.