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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Hansen Medical Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Hansen Medical Inc is recalling Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, C due to The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduct. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026