| Date Initiated by Firm | April 16, 2003 |
|---|
| Date Posted | May 14, 2003 |
|---|
| Recall Status1 |
Terminated 3 on July 20, 2004 |
| Recall Number | Z-0818-03 |
|---|
| Recall Event ID |
26136 |
| 510(K)Number | K010068 |
|---|
| Product Classification |
Prosthesis, Esophageal - Product Code ESW
|
| Product | Polyflex Esophageal Stent 20/16mm x 90mm |
|---|
| Code Information |
Reorder Number: M00514270 Lot Numbers: 03101, 03071 |
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Boston Scientific Place
Natick MA 01760
|
| For Additional Information Contact | Robert T. Miragliulo
508-652-35186 |
|---|
Manufacturer Reason
for Recall | Radiopaque marker bands may not be visible under fluoroscopy |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 5 |
|---|
| Distribution | Nationwide |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = ESW
|
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