510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-2106-2008

Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA...

Hansen Medical, Inc. / initiated 2008-05-21 / Terminated / root cause: design
FDA source (opens on fda.gov)

Hansen Medical Inc began a recall of Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2106-2008
Status
Terminated
Initiated
Posted
Terminated
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.
Product code
DRA Catheter, Steerable
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.
Root cause tag
design
FDA 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 in commerce
369 units
Distribution
Class II Recall - Worldwide Distribution ---- including USA and countries of UK, Italy, Germany, and Czech Republic.
Product codes and lots
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.