—#91999

Product

Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number M00513720. 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 Numbers: 11737197, 11773676, 11873568, 11930246, 11931993, 12106608, 12123123, 12321371, 12353709, 1242701, 12440418, 12458739, 12601203, 12603432, 12879476, 12898127, 12921104

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 #91999. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.