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.
This recall has been terminated (originally issued December 23, 2010).
- Recall Initiated
- November 12, 2010
- Posted
- December 23, 2010
- Terminated
- May 17, 2011
- Recall Number
- Z-0789-2011
- Quantity
- 4,962 (3,858 US; 1,104 OUS)
- Firm Location
- Plymouth, MN
- Official Source
- View on FDA website ↗
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.
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,
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.