Polyflex Esophageal Stent 23/18mm x 150mm
FDA device recall Z-0823-03 · posted 2003-05-14 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Radiopaque marker bands may not be visible under fluoroscopy
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- ESW
- Quantity affected
- 5
- Distribution
- Nationwide
- Date initiated
- 2003-04-16
- Date posted
- 2003-05-14
- Date terminated
- 2004-07-20
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM (K010068) | Rusch Intl. | 2001-02-08 |