Date Initiated by Firm |
January 29, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on November 08, 2005 |
Recall Number |
Z-0614-04 |
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 Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 14 mm 80 cm .014" REF PMB 4-5-14-80 |
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.
|
FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
446 |
Distribution |
The product was distributed nationwide in the United States and internationally to China and Ireland. |
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 and Original Applicant = EV3 INC
|