Investors



  • FOR INFORMATION ON
    REPORTING CHANGES AND
    REVISED REVENUE GUIDANCE click here.


  • FOR GIVEN IMAGING
    ACQUISITION INFORMATION, click here.


  • FOR 2013 INVESTOR DAY MATERIALS,
    click here.


  • For Pharmaceuticals
    spin-off information,
    click here.


  • For tax basis information
    due to the Mallinckrodt spin,
    click here.


News Release

Printer Friendly Version View printer-friendly version
<< Back
ev3 Initiates Voluntary Recall of Specific Lots of NanoCross .014" OTW PTA Dilatation Catheter

PLYMOUTH, Minn.--(BUSINESS WIRE)--ev3, a Covidien company, has initiated a voluntary recall of specific lots of the NanoCross™ .014" OTW PTA Dilatation Catheter due to the potential for the catheter shaft to crack or break during use. Cracking or breaking of the catheter shaft may result in the inability to inflate or deflate the balloon, and may result in material separation and potential embolization. The device failure may lead to unplanned intravascular or open surgery, significant vasospasm, prolonged tissue ischemia, injury, infarct, bleeding and/or death.

The Food and Drug Administration (FDA) has classified the recall as a Class I recall. The FDA classifies a recall as Class I when the agency believes there is a reasonable probability that the use of the recalled product will cause serious adverse health consequences or death.

The NanoCross 0.014" OTW PTA Dilatation Catheter is 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. The NanoCross Dilatation Catheter is not an implant. It is removed and discarded after the procedure is completed.

The voluntary recall affects certain lots of the NanoCross .014" OTW PTA Dilatation Catheters manufactured between May 27, 2010, and October 18, 2010. Only the NanoCross .014" OTW PTA Dilatation Catheters from lot numbers listed below is affected by this action. All affected healthcare facilities have been notified of this action in a letter dated November 10, 2010. Healthcare facilities should take immediate action to locate and remove from use the specified NanoCross PTA Dilatation Catheters. Detailed steps were provided in the Customer Notification letter for return and disposition of affected products.

Affected ev3 NanoCross™ .014" OTW PTA Dilatation Catheter Product Catalog / Lot Numbers

Cat #
AB14W020040150

   

Cat. #
AB14W02008010

   

Cat. # AB14W020120150

   

Cat. # AB14W020150150

 
Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8631564 8672990 8672994 8746781
8664386 8710423 8755401 8784859
8703047 8778807 8755602 8798136

8743036

8778808 8755604 8827211
8745610 8789928 8784858 8851945
8749903 8811586 8795999 8964937
8784866 8837970 8810475
8792531 9153521 9023725
8821432 9222820 9050028
8837969 9074214
8847440 9088260
8871669 9146365
9209927 9198871
9209680
9235823
9248597
9254604
            9266768      

Cat. # AB14W020210150

Cat. # AB14W025040150

Cat. # AB14W025080150

Cat. # AB14W025120150

Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8778745 8746902 8664384 8722274
8778748 8746903 8711789 8722275
8778749 8749908 8741778 8722277
8789891 8784864 8778813 8741791
8810468 8810470 8796007 8745616
8821428 8826743 8821434 8815365
9097151 8846663 8846664 8815410
9195071 8915544 9218102 9013770
9214883 8985597 9232283 9023719
9216811 9235612 9082516
9221177 9097149
9231361 9178997
9238413 9222934
9254886
                  9270248

Cat. # AB14W025150150

   

Cat. # AB14W025210150

   

Cat. # AB14W030040150

   

Cat. # AB14W030080150

Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8789931 8744140 8630847 8674379
8810473

8757219

8703042 8710383
8827208 8826331 8703044 8745612
8854221 8826333 8703050 8757468
8877645 8826336 8737491 8795994
8989919 9082532 8741794 8816902
9237414 9155514 8755622 8838736
9180316 8789946 9153523
9209447 8796008 9203512
9222907 8841532 9221180
9233059 8842327 9232658
9238795 8847442 9237412
8871667
8916474
8985601
9217289
            9221183      

Cat. # AB14W030120150

Cat.# AB14W030150150

Cat.# AB14W030210150

Cat.# AB14W035040150

Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8711873 8741786 8815676 8705822
8741781 8749899 8816203 8784860
8755603 8789924 8816467 8853567
8784854 8810474 8821338 8989918
8792133 8836819 8821419
8810472 8871664 8836748
9023729 8970944 8847435
9062683 9083740
9097148 9148256
9179000 9194250
9224585 9216747
9231360 9221182
9248574 9235807
9254782 9263491
9286411                  

Cat.# AB14W035080150

Cat.# AB14W035120150

Cat.# AB14W035150150

Cat.# AB14W035210150

Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8757061 8703049 8822758 8789883
8815414 8815409 8828189
9078466 9078464 9208439
9248425 9208441 9221817
      9286249            

Cat.# AB14W040040150

Cat.# AB14W040080090

Cat.# AB14W040080150

Cat.# AB14W040120150

Lot Numbers: Lot Numbers: Lot Numbers: Lot Numbers:
8629968 9220075 8722279 8738444
8657024 9225648 8749882 8749895
8755600 8787509 8778810
8755601 8822999 8789939
8755625 9216848 8822880
8789935 9224246 9000723
8821431 9237413 9018516
8842537 9097147
8877650 9194251
8970943 9204433
9209903 9248553
9263037
                  9283623

Cat.# AB14W040210150

Cat.# AB14W040150150

Lot Numbers: Lot Numbers:
8741777 8747184
8751214 8796001
8784853 8837761
8810467 8873813
8822411
8836749
9235780
9245449                  

The lot numbers for all NanoCross .014” OTW PTA Dilatation Catheters are clearly printed on the front and sides of the product packaging.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.