Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model
FDA device recall Z-1251-2010 · posted 2010-04-06 · Terminated
Recall details
- Recalling firm
- Hansen Medical Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXX
- Distribution
- Nationwide to 12 states.
- Date initiated
- 2009-10-19
- Date posted
- 2010-04-06
- Date terminated
- 2011-02-09
- Location
- Mountain View, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HANSEN MEDICAL ARTISAN S CONTROL CATHETER (K090365) | Hansen Medical, Inc. | 2009-05-07 |