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.

“OTW PTA Dilatation Catheters manufactured between May 27, 2010, and October 18, 2010. Only the NanoCross .014”

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.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: [phone]
• Phone: [phone]