The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arteri
FDA device recall Z-1089-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- The marker band in guidewire lumen could move from the manufactured location during clinical use.
- Action taken
- letter 5/21/2004, representative visit to foreign accounts.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXE
- Quantity affected
- 1010 of all affected lots
- Distribution
- Nationwide, worldwide
- Date initiated
- 2004-05-12
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-03
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K032763) | Vascular Solutions, Inc. | 2003-12-19 |