Class I Medical Device Recall: ev3 NanoCross .014 OTW PTA Dilatation Catheter

Recall Class: Class I

Date Recall Initiated: November 10, 2010

Product: NanoCross .014" PTA Balloon Catheter

Manufacturing From: May 27, 2010 – October 18, 2010

Distribution From: June 8, 2010 – November 4, 2010

The following model and lot numbers affected can be found using the following List Number Configurations:

Model Number - Country/ Language Code - Inventory Code	Lot Number - Country/ Language Code - Inventory Code
AB14W020040150	8631564 8664386 8703047 8743036 8745610 8749903 8784866 8792531 8821432 8837969 8847440 8871669 9209927
AB14W020080150	8672990 8710423 8778807 8778808 8789928 8811586 8837970 9153521 9222820
AB14W020120150	8672994 8755401 8755602 8755604 8784858 8795999 8810475 9023725 9050028 9074214 9088260 9146365 9198871 9209680 9235823 9248597 9254604 9266768
AB14W020150150	8746781 8784859 8798136 8827211 8851945 8964937
AB14W020210150	8778745 8778748 8778749 8789891 8810468 8821428 9097151 9195071 9214883 9216811 9221177 9231361 9238413
AB14W025040150	8746902 8746903 8749908 8784864 8810470 8826743 8846663 8915544 8985597 9235612
AB14W025080150	8664384 8711789 8741778 8778813 8796007 8821434 8846664 9218102 9232283
AB14W025120150	8722274 8722275 8722277 8741791 8745616 8815365 8815410 9013770 9023719 9082516 9097149 9178997 9222934 9254886 9270248
AB14W025150150	8789931 8810473 8827208 8854221 8877645 8989919 9237414
AB14W025210150	8744140 8757219 8826331 8826333 8826336 9082532 9155514 9180316 9209447 9222907 9233059 9238795
AB14W030040150	8630847 8703042 8703044 8703050 8737491 8741794 8755622 8789946 8796008 8841532 8842327 8847442 8871667 8916474 8985601 9217289 9221183
AB14W030080150	8674379 8710383 8745612 8757468 8795994 8816902 8838736 9153523 9203512 9221180 9232658 9237412
AB14W030120150	8711873 8741781 8755603 8784854 8792133 8810472 9023729 9062683 9097148 9179000 9224585 9231360 9248574 9254782 9286411
AB14W030150150	8741786 8749899 8789924 8810474 8836819 8871664 8970944
AB14W030210150	8815676 8816203 8816467 8821338 8821419 8836748 8847435 9083740 9148256 9194250 9216747 9221182 9235807 9263491
AB14W035040150	8705822 8784860 8853567 8989918
AB14W035080150	8757061 8815414 9078466 9248425
AB14W035120150	8703049 8815409 9078464 9208441 9286249
AB14W035150150	8822758
AB14W035210150	8789883 8828189 9208439 9221817
AB14W040040150	8629968 8657024 8755600 8755601 8755625 8789935 8821431 8842537 8877650 8970943 9209903
AB14W040080090	9220075 9225648
AB14W040080150	8722279 8749882 8787509 8822999 9216848 9224246 9237413
AB14W040120150	8738444 8749895 8778810 8789939 8822880 9000723 9018516 9097147 9194251 9204433 9248553 9263037 9283623
AB14W040210150	8741777 8751214 8784853 8810467 8822411 8836749 9235780 9245449
AB14W040150150	8747184 8796001 8837761 8873813

Use: The NanoCross 0.014” OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries. It is also used for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The NanoCross Dilatation Catheter is not an implant. It is removed and discarded after the procedure is completed.

Recalling Firm:

ev3
4600 Nathan Ln N
Plymouth, Minnesota 55442-2890

Reason for Recall: There is potential for cracking or breaking during use. Cracking or breaking of the catheter shaft can result in the inability to inflate or deflate the balloon, and can result in separation of catheter components and potential embolization catheter fragments. Catheter failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.

Public Contact: Questions should be directed to ev3 at 763-398-7000.

FDA District: Minneapolis

FDA Comments:

In a letter dated November 10, 2010, ev3 notified healthcare facilities of the NanoCross .014” OTW PTA Dilatation Catheters voluntary recall. In this letter, it was requested that all affected products are located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Useful Links:

• News Release: ev3 Initiates Voluntary Recall of Specific Lots of NanoCross .014" OTW PTA Dilatation Catheter
• MedWatch: The FDA Safety Information and Adverse Event Reporting Program