Recall Z-0826-03 ยท ESW Prosthesis, Esophageal
Boston Scientific Corporation
Polyflex Esophageal Stent 25/21mm x 150mm
| Date | May 14, 2003 (initiated Apr 16, 2003) |
| Status | Terminated |
| Reason | Radiopaque marker bands may not be visible under fluoroscopy |
| Root cause | Other |
| Action | Boston Scientific notified domestic accounts by letter on April 16, 2003. The account wasinstructed to check inventory and return product. A Reply Verification form was provided to document amount of product in inventory. |
| Quantity | 3 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010068 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM Rusch Intl., Feb 8, 2001 |