Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide c
FDA device recall Z-2106-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Hansen Medical Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DRA
- Quantity affected
- 369 units
- Distribution
- Class II Recall - Worldwide Distribution ---- including USA and countries of UK, Italy, Germany, and Czech Republic.
- Date initiated
- 2008-05-21
- Date posted
- 2008-09-11
- Date terminated
- 2009-05-27
- 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 CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH (K052480) | Hansen Medical, Inc. | 2007-05-02 |