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ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized… recallZ-0789-2011 · Ev3, Inc. · initiated Nov 12, 2010

Terminated All recalls posted in December 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ev3, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0789-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 12, 2010
Posted by the FDA
Dec 23, 2010
Recalling firm
Ev3, Inc.
Quantity
4,962 (3,858 US; 1,104 OUS)
Product code
DQY
FDA submissions
K082854, K090849
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,

Product description

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 (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Other devices under the same FDA submission

3 devices cleared under K082854, K090849 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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