ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .018"
FDA device recall Z-0617-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- ev3, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 446
- Distribution
- The product was distributed nationwide in the United States and internationally to China and Ireland.
- Date initiated
- 2004-01-29
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-08
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM (K033134) | Ev3, Inc. | 2003-11-17 |