Recall Z-1861-2010 ยท ESW Prosthesis, Esophageal
Boston Scientific Corporation
Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/10/7. Catalog Number M00513730. 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.
| Date | Jun 25, 2010 (initiated May 17, 2010) |
| Status | Terminated |
| Reason | Suture related device failures during deployment and repositioning of the stent |
| Root cause | Device Design |
| 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. |
| Distribution | Worldwide Distribution - Only US distributed product is affected by recall |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032930 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corp, Oct 23, 2003 |