Z-1251-2010

Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter...

Name: Z-1251-2010 Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter...
Creator: Hansen Medical Inc
Published: 2009-10-19
License: https://open.fda.gov/license/

Hansen Medical, Inc. / initiated 2009-10-19 / Terminated

FDA source

Hansen Medical Inc began a recall of Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and... on 2009-10-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1251-2010
Status: Terminated
Initiated: 2009-10-19
Posted: 2010-04-06
Terminated: 2011-02-09
Recalling firm: Hansen Medical, Inc.
Product: 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
Product code: DXX System, Catheter Control, Steerable
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.
FDA root cause: Other
Action: 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.
Distribution: Nationwide to 12 states.
Product codes and lots: 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

Product code DXX

K090365Class IIHansen Medical Artisan S Control CatheterHansen Medical, Inc. / cleared 2009-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)