Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA
This recall has been terminated (originally issued April 6, 2010).
- Company
- Hansen Medical Inc
- Recall Initiated
- October 19, 2009
- Posted
- April 6, 2010
- Terminated
- February 9, 2011
- Recall Number
- Z-1251-2010
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter.
Distribution
Nationwide to 12 states.
Lot / Code Info
Serial Numbers: 6394, 6376, 6377, 6378, 6379, 6380, 6381, 6382, 6383, 6384, 6385, 6386, 6387, 6388, 6389, 6390, 6392, 6393, 6395, 6396, 6397, 6398, 6399, 6400, 6401, 6402, 6403, 6406, 6407, 6408, 6409, 6410, 6411, 6412, 6413, 6414, 6415, 6417, 6418, 6419, 6420, 6421, 6422, 6423, 6424, 6425, 6427, 6428, 6429, 6430, 6431, 6432, 6433, 6434, 6435, 6436, 6437, 6438, 6439, 6440, 6441, 6442, 6443, 6444, 6445, 6446, 6447, 6448, 6449, 6450, 6451, 6452, 6453, 6454, 6455, 6456, 6457, 6458, 6459, 6460, 6461, 6462, 6463, 6464, 6465, 6466, 6467, 6468, 6469, 6470, 6471, 6472, 6473, 6474, 6475, 6476, 6477, 6478, 6479, 6480, 6481, 6482, 6483, 6484, 6485, 6486, 6487, 6488, 6489, 6490, 6491, 6492, 6493, 6494, 6495, 6496, 6497, 6498, 6499, 6501, 6502, 6504, 6505, 6506, 6507, 6508, 6509, 6511, 6513, 6514, 6515, 6516, 6517, 6519, 6520, 6522, 6523, 6524, 6525, 6526, 6527, 6528, 6530, 6532, 6533, 6534, 6537, 6542, 6543, 6544, 6549, 6556, 6562, 6564, 6566, 6569, 6570, 6573, 6574, 6575, 6577, 6578, 6580, 6582, 6585, 6586, 6588, 6589, 6591, 6593, 6596, 6598, 6599, 6600, 6601, 6608, 6612, 6615, 6616, 6620, 6621, 6626, 6627, 6633, 6635, 6636, 6638
Root Cause
Other
Action Taken
Recall Initiation Date: October 19,2009 (FedEx shipments on October 19, for October 20 delivery) via letters explaining the reason for the recall and requesting the product be returned. Customers with questions are instructed to call the company at 650-404-5940.