FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2106-2008
- Recalling firm
- Hansen Medical Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-05-21
- Posted
- 2008-09-11
- Terminated
- 2009-05-27
- 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.
- Lot, serial or model codes
- Lot numbers: 2182, 2185, 2186, 2199, 2200-2203, 2205, 2206, 2008, 2213-2218, 2220, 2223-2231, 2233, 2234, 2236-2245, 2247, 2249, 2251, 2261-2263, 2265, 2267-2271, 2273, 2274, 2276-2279, 2284, 2288-2297, 2301-2303, 2305, 2309, 2315, 2318, 2320-2322, 2324, 2327, 2328, 2330, 2332, 2334, 2342, 2344-2349, 2351, 2353, 2355-2357, 2359-2363, 2366-2367, 2370, 2370, 2374-2375, 2377-2378, 2381-2382, 2384, 2387-2389, 2391, 2392, 2394,2395, 2397, 2399, 2400, 2404, 2405, 2412, 2417, 2420, 2421, 2423-2426, 2429, 2430, 2432-2434, 2436, 2442, 2444, 2446-2448, 2450, 2453, 2457-2461, 2463-2467, 2469-2472, 2475-2483, 2485-2490, 2494, 2497, 2500, 2502-2504, 2508, 2510, 2512-2518, 2522, 2526, 2529, 2531-2532, 2534, 2536, 2538, 2539, 2547, 2549, 2551, 2553, 2556, 2558-2560, 2562-2565, 2568, 2569, 2571, 2574-2577, 2579, 2581-2582, 2586, 2588-2589, 2591-2596, 2601, 2604, 2609, 2610, 2612, 2617, 2619, 2626, 2627, 2636, 2637, 2639-2642, 2644, 2675, 2682, 2684, 2685, 2688, 2689, 2698-2699, 2701-2707, 2709, 2716, 2720, 2722-2723, 2726-2727, 2729, 2732-2735, 2738, 2741, 2743, 2745, 2746, 2752, 2754-2757, 2761, 2767, 2773-2774, 2776, 2779, 2782, 2783, 2785-2789, 2791, 2797-2798, 2801, 2803-2804, 2806, 2809, 2812, 2814-2815, 2817-2818, 2821, 2822, 2824, 2827, 2829-2831, 2833-2837, 2839, 2843, 2848, 2850, 2854, 2857, 2862, 2865, 2872, 2879, 2882, 2886, 2888, 2889, 2894, 2896, 2898, 2904, 2908-2909, 2913, 2915, 2920, 2922, 2924, 2925, 2930, 2932, and 2940.
- 510(k) numbers
- ["K052480"]
- PMA numbers
- not on file
- Product code
- DRA
- Firm FEI
- 3006026430
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28