Class 1 Device Recall ev3 NanoCross 0.14 OTW PTA Dilatation Catheter

• Date Initiated by Firm: November 12, 2010
• Date Posted: December 23, 2010
• Recall Status: Terminated on May 17, 2011
• Recall Number: Z-0789-2011
• Recall Event ID: 57335
• 510(K)Number: K082854 K090849
• Product Classification: Percutaneous Catheter - 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 MN 55442-2890
• For Additional Information Contact: 763-398-7000
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQY