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U.S. Department of Health and Human Services

Medical Devices

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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
AB14W0200401508631564
8664386
8703047
8743036
8745610
8749903
8784866
8792531
8821432
8837969
8847440
8871669
9209927
AB14W0200801508672990
8710423
8778807
8778808
8789928
8811586
8837970
9153521
9222820
AB14W0201201508672994
8755401
8755602
8755604
8784858
8795999
8810475
9023725
9050028
9074214
9088260
9146365
9198871
9209680
9235823
9248597
9254604
9266768
AB14W0201501508746781
8784859
8798136
8827211
8851945
8964937
AB14W0202101508778745
8778748
8778749
8789891
8810468
8821428
9097151
9195071
9214883
9216811
9221177
9231361
9238413
AB14W0250401508746902
8746903
8749908
8784864
8810470
8826743
8846663
8915544
8985597
9235612
AB14W0250801508664384
8711789
8741778
8778813
8796007
8821434
8846664
9218102
9232283
AB14W0251201508722274
8722275
8722277
8741791
8745616
8815365
8815410
9013770
9023719
9082516
9097149
9178997
9222934
9254886
9270248
AB14W0251501508789931
8810473
8827208
8854221
8877645
8989919
9237414
AB14W0252101508744140
8757219
8826331
8826333
8826336
9082532
9155514
9180316
9209447
9222907
9233059
9238795
AB14W0300401508630847
8703042
8703044
8703050
8737491
8741794
8755622
8789946
8796008
8841532
8842327
8847442
8871667
8916474
8985601
9217289
9221183
AB14W0300801508674379
8710383
8745612
8757468
8795994
8816902
8838736
9153523
9203512
9221180
9232658
9237412
AB14W0301201508711873
8741781
8755603
8784854
8792133
8810472
9023729
9062683
9097148
9179000
9224585
9231360
9248574
9254782
9286411
AB14W0301501508741786
8749899
8789924
8810474
8836819
8871664
8970944
AB14W0302101508815676
8816203
8816467
8821338
8821419
8836748
8847435
9083740
9148256
9194250
9216747
9221182
9235807
9263491
AB14W0350401508705822
8784860
8853567
8989918
AB14W0350801508757061
8815414
9078466
9248425
AB14W0351201508703049
8815409
9078464
9208441
9286249
AB14W0351501508822758
AB14W0352101508789883
8828189
9208439
9221817
AB14W0400401508629968
8657024
8755600
8755601
8755625
8789935
8821431
8842537
8877650
8970943
9209903
AB14W0400800909220075
9225648
AB14W0400801508722279
8749882
8787509
8822999
9216848
9224246
9237413
AB14W0401201508738444
8749895
8778810
8789939
8822880
9000723
9018516
9097147
9194251
9204433
9248553
9263037
9283623
AB14W0402101508741777
8751214
8784853
8810467
8822411
8836749
9235780
9245449
AB14W0401501508747184
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.

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