Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/10/7. Catalog Number M00514240. Single Use
FDA device recall Z-1872-2010 · posted 2010-06-25 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Suture related device failures during deployment and repositioning of the stent
- Action taken
- 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
- Status
- Terminated
- Product code
- ESW
- Distribution
- Worldwide Distribution - Only US distributed product is affected by recall
- Date initiated
- 2010-05-17
- Date posted
- 2010-06-25
- Date terminated
- 2011-10-20
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K032930) | Boston Scientific Corp | 2003-10-23 |