Recall Z-1251-2010 ยท DXX System, Catheter Control, Steerable
Hansen Medical Inc
Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA
| Date | Apr 6, 2010 (initiated Oct 19, 2009) |
| Status | Terminated |
| Reason | Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter. |
| Root cause | Other |
| Action | Recall Initiation Date: October 19,2009 (FedEx shipments on October 19, for October 20 delivery) via letters explaining the reason for the recall and requesting the product be returned. Customers with questions are instructed to call the company at 650-404-5940. |
| Distribution | Nationwide to 12 states. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090365 | HANSEN MEDICAL ARTISAN S CONTROL CATHETER Hansen Medical, Inc., May 7, 2009 |