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U.S. Department of Health and Human Services

Class 1 Device Recall ev3 NanoCross 0.14 OTW PTA Dilatation Catheter

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 Class 1 Recall
ev3 NanoCross 0.14 OTW PTA Dilatation Catheter
see related information
Date Posted December 23, 2010
Recall Status1 Terminated on May 17, 2011
Recall Number Z-0789-2011
Recall Event ID 57335
Premarket Notification
510(K) Numbers
K082854  K090849 
Product Classification Catheter, Percutaneous - Product Code DQY
Product ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14W020120150, AB14W030080150, AB14W035120150, AB14W035040150, AB14W030120150, AB14W025120150, AB14W040080150, AB14W040120150, AB14W040210150, AB14W030150150, AB14W025210150, AB14W020150150, AB14W025040150, AB14W040150150, AB14W035080150, AB14W020210150, AB14W035210150, AB14W025150150, AB14W030210150, AB14W035150150, AB14W040080090, Intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is an over the wire (OTW) 0.014" coaxial lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter shaft and the balloon has a hydrophilic coating. The manifold includes a lumen marked "THRU". This is the central lumen of the catheter that terminates at the distal tip. This lumen is used to pass the catheter over a guide wire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is used to inflate and deflate the dilatation balloon with a solution of contrast medium and saline. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. The 210mm balloon contains two additional radiopaque marker bands that denote the middle of the balloon body.
Code Information Lot No.: 8629968, 8630847, 8631564, 8657024, 8664384, 8664386, 8672990, 8672994, 8674379, 8703042, 8703044, 8703047, 8703049, 8703050, 8705822, 8710383, 8710423, 8711789, 8711873, 8722274, 8722275, 8722277, 8722279, 8737491, 8738444, 8741777, 8741778, 8741781, 8741786, 8741791, 8741794, 8743036, 8744140, 8745610, 8745612, 8745616, 8746781, 8746902, 8746903, 8747184, 8749882, 8749895, 8749899, 8749903, 8749908, 8751214, 8755401, 8755600, 8755601, 8755602, 8755603, 8755604, 8755622, 8755625, 8757061, 8757219, 8757468, 8778745, 8778748, 8778749, 8778807, 8778808, 8778810, 8778813, 8784853, 8784854, 8784858, 8784859, 8784860, 8784864, 8784866, 8787509, 8789883, 8789891, 8789924, 8789928, 8789931, 8789935, 8789939, 8789946, 8792133, 8792531, 8795994, 8795999, 8796001, 8796007, 8796008, 8798136, 8810467, 8810468, 8810470, 8810472, 8810473, 8810474, 8810475, 8811586, 8815365, 8815409, 8815410, 8815414, 8815676, 8816203, 8816467, 8816902, 8821338, 8821419, 8821428, 8821431, 8821432, 8821434, 8822411, 8822758, 8822880, 8822999, 8826331, 8826333, 8826336, 8826743, 8827208, 8827211, 8828189, 8836748, 8836749, 8836819, 8837761, 8837969, 8837970, 8838736, 8841532, 8842327, 8842537, 8846663, 8846664, 8847435, 8847440, 8847442, 8851945, 8853567, 8854221, 8871664, 8871667, 8871669, 8873813, 8877645, 8877650, 8915544, 8916474, 8964937, 8970943, 8970944, 8985597, 8985601, 8989918, 8989919, 9000723, 9013770, 9018516, 9023719, 9023725, 9023729, 9050028, 9062683, 9074214, 9078464, 9082516, 9082532, 9083740, 9088260, 9097147, 9097148, 9097149, 9097151, 9146365, 9148256, 9153520, 9153521, 9153523, 9155514, 9178997, 9179000, 9180316, 9194250, 9194251, 9195071, 9198871, 9203512, 9204433, 9208439, 9208441, 9209447, 9209680, 9209903, 9209927, 9214883, 9216747, 9216811, 9216848, 9217289, 9218102, 9220075, 9221177, 9221180, 9221182, 9221183, 9221817, 9222820, 9222907, 9222934, 9224246, 9224585, 9225648, 9231360, 9231361, 9232283, 9232658, 9233059, 9235612, 9235780, 9235807, 9235823, 9237412, 9237413, 9238413, 9238795, 9245449, 9248425, 9248553, 9248574, 9248597, 9251552, 9254604, 9254782, 9254886, 9263037, 9263491, 9266768, 9270248, 9283623, 9286249, and 9286411.
Recalling Firm/
Manufacturer
Ev3, Inc.
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
ev3 has determined that specific lots of the NanoCross .014 OTW PTA Dilatation catheters may crack or break during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in material separation and potential embolization.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action A Medical Device Recall letter addressed to Risk Managers, dated 11/10/2010, was sent to hospitals beginning 11/12/2010. The letter identified the affected devices, described the issue and requested that affected devices be located and removed from use. ev3 sales representatives will contact customers to arrange return of all unused devices. A credit or replacement will be provided for any unused devices. Questions regarding this issue may be directed towards Customer Service at 800-716-6700.
Quantity in Commerce 4,962 (3,858 US; 1,104 OUS)
Distribution Worldwide Distribution -- USA, AUSTRALIA, BELGIUM, BRAZIL, BULGARIA, CANADA, CHILE, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MALTA, NETHERLANDS, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SYRIA, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM,
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 = DQY and Original Applicant = EV3 INC.
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