Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/12/9. Catalog Number M00513740. 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 Recall Z-1862-2010 · Posted 2010-06-25
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeESW
Date Initiated2010-05-17
Date Terminated2011-10-20
Reason for Recall
Suture related device failures during deployment and repositioning of the stent
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - Only US distributed product is affected by recall
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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