| Date Initiated by Firm | January 29, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on November 08, 2005 |
| Recall Number | Z-0618-04 |
|---|
| Recall Event ID |
28210 |
| 510(K)Number | K033134 |
|---|
| Product Classification |
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
|
| Product | ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80 |
|---|
| Code Information |
Lots 262849 through 445216 |
Recalling Firm/
Manufacturer |
ev3, Inc.
651 Campus Dr
Saint Paul MN 55112-3495
|
Manufacturer Reason
for Recall | After stent deployment, resistance can occur when pulling the deflated balloon back into the guiding catheter and this can result in an increased procedure time. |
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FDA Determined
Cause 2 | Other |
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| Action | A recall letter was sent by Fed Ex to all affected customers for delivery on 01/30/04. Follow-up and product retrieval was done by the firm''s representatives. |
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| Quantity in Commerce | 446 |
|---|
| Distribution | The product was distributed nationwide in the United States and internationally to China and Ireland. |
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| 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 = FGE
|
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