• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Artisan brand Extend Control Catheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Artisan brand Extend Control Catheter
see related information
Date Posted April 06, 2010
Recall Status1 Terminated on February 09, 2011
Recall Number Z-1251-2010
Recall Event ID 54144
Premarket Notification
510(K) Number
K090365 
Product Classification System, Catheter Control, Steerable - Product Code DXX
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
Code Information 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
Recalling Firm/
Manufacturer
Hansen Medical Inc
380 N. Bernardo Ave.
Mountain View, California 94043-5207
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Doug Worth
650-404-5940
Manufacturer 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 Determined
Cause 2
OTHER/UNDETERMINED: Pending
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DXX and Original Applicant = HANSEN MEDICAL, INC.
-
-