Recall Z-1089-04 ยท DXE Catheter, Embolectomy
Vascular Solutions, Inc.
The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
| Date | Jul 20, 2004 (initiated May 12, 2004) |
| Status | Terminated |
| Reason | The marker band in guidewire lumen could move from the manufactured location during clinical use. |
| Root cause | Other |
| Action | letter 5/21/2004, representative visit to foreign accounts. |
| Quantity | 1010 of all affected lots |
| Distribution | Nationwide, worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032763 | VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER Vascular Solutions, Inc., Dec 19, 2003 |