Recall Z-0613-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ev3, Inc.
ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80
| Date | Jul 20, 2004 (initiated Jan 29, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 446 |
| Distribution | The product was distributed nationwide in the United States and internationally to China and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033134 | MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM Ev3, Inc., Nov 17, 2003 |