Recalls / —
—#27152
Product
Polyflex Esophageal Stent 23/18mm x 150mm
- FDA product code
- ESW — Prosthesis, Esophageal
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K010068
- Affected lot / code info
- Reorder Number: M00514320 Lot Numbers: 03101, 03071
Why it was recalled
Radiopaque marker bands may not be visible under fluoroscopy
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Place, Natick, Massachusetts 01760
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2003-04-16
- Posted by FDA
- 2003-05-14
- Terminated
- 2004-07-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #27152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.