Recall Z-2106-2008 ยท DRA Catheter, Steerable
Hansen Medical Inc
Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria.
| Date | Sep 11, 2008 (initiated May 21, 2008) |
| Status | Terminated |
| Reason | The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism. |
| Root cause | Device Design |
| Action | On May 21, 2008 an Urgent: Voluntary Product Recall Notification was issued. All customers who received affected product were verbally contacted directly by the firm, and were sent a follow up letter, asking them to segregate the product. Replacements will be shipped to them. If you have questions please contact Doug Worth at 1-650-404-5940. |
| Quantity | 369 units |
| Distribution | Class II Recall - Worldwide Distribution ---- including USA and countries of UK, Italy, Germany, and Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH Hansen Medical, Inc., May 2, 2007 |