ev3 Initiates Voluntary Recall of Specific Lots of NanoCross™ .014" OTW PTA Dilatation Catheter28 December 2010, 5:29 pm Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company. ev3 Initiates Voluntary Recall of Specific Lots of NanoCross™ .014" OTW PTA Dilatation Catheter
Contacts:Rachel Bloom Baglin
Vice President, Communications
Vascular Therapies
508-261-6651
rachel.bloombaglin@covidien.com Bruce Farmer
Vice President
Public Relations
508-452-4372
bruce.farmer@covidien.com Cole Lannum, CFA
Vice President
Investor Relations
508-452-4343
cole.lannum@covidien.com FOR IMMEDIATE RELEASE – Plymouth, MN – December 15, 2010 - ev3, a Covidien company, has initiated a voluntary recall of specific lots of the 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, tissue, injury, infarct, bleeding and/or death. The
Food and Drug Administration(FDA) has classified the recall as a Class I recall. 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.
ev3 NanoCross™ .014" OTW PTA Dilatation Catheter Product Catalog / Lot Numbers | Cat. # AB14W020040150[/t][/t][/t][/t][/t][/t] |
|
[tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]
8631564
[/td] [/tr] [tr] [td]
8664386
[/td] [/tr] [tr] [td]
8703047
[/td] [/tr] [tr] [td]
8743036
[/td] [/tr] [tr] [td]
8745610
[/td] [/tr] [tr] [td]
8749903
[/td] [/tr] [tr] [td]
8784866
[/td] [/tr] [tr] [td]
8792531
[/td] [/tr] [tr] [td]
8821432
[/td] [/tr] [tr] [td]
8837969
[/td] [/tr] [tr] [td]
8847440
[/td] [/tr] [tr] [td]
8871669
[/td] [/tr] [tr] [td]
9209927
[/td] [/tr] [td]
Cat. # AB14W020080150 |
| Lot Numbers: |
8672990 |
8710423 |
8778807 |
8778808 |
8789928 |
8811586 |
8837970 |
9153521 |
9222820 |
[/td] [td]
Cat. # AB14W020120150 |
| Lot Numbers: |
8672994 |
8755401 |
8755602 |
8755604 |
8784858 |
8795999 |
8810475 |
9023725 |
9050028 |
9074214 |
9088260 |
9146365 |
9198871 |
9209680 |
9235823 |
9248597 |
9254604 |
9266768 |
[/td] [td]
Cat. # AB14W020150150 |
| Lot Numbers: |
8746781 |
8784859 |
8798136 |
8827211 |
8851945 |
8964937 |
[/td] [tr] [td]
[tr] [td]Cat. # AB14W020210150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8778745[/td] [/tr] [tr] [td]8778748[/td] [/tr] [tr] [td]8778749[/td] [/tr] [tr] [td]8789891[/td] [/tr] [tr] [td]8810468[/td] [/tr] [tr] [td]8821428[/td] [/tr] [tr] [td]9097151[/td] [/tr] [tr] [td]9195071[/td] [/tr] [tr] [td]9214883[/td] [/tr] [tr] [td]9216811[/td] [/tr] [tr] [td]9221177[/td] [/tr] [tr] [td]9231361[/td] [/tr] [tr] [td]9238413[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat. # AB14W025040150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8746902[/td] [/tr] [tr] [td]8746903[/td] [/tr] [tr] [td]8749908[/td] [/tr] [tr] [td]8784864[/td] [/tr] [tr] [td]8810470[/td] [/tr] [tr] [td]8826743[/td] [/tr] [tr] [td]8846663[/td] [/tr] [tr] [td]8915544[/td] [/tr] [tr] [td]8985597[/td] [/tr] [tr] [td]9235612[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat. # AB14W025080150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8664384[/td] [/tr] [tr] [td]8711789[/td] [/tr] [tr] [td]8741778[/td] [/tr] [tr] [td]8778813[/td] [/tr] [tr] [td]8796007[/td] [/tr] [tr] [td]8821434[/td] [/tr] [tr] [td]8846664[/td] [/tr] [tr] [td]9218102[/td] [/tr] [tr] [td]9232283[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat. # AB14W025120150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8722274[/td] [/tr] [tr] [td]8722275[/td] [/tr] [tr] [td]8722277[/td] [/tr] [tr] [td]8741791[/td] [/tr] [tr] [td]8745616[/td] [/tr] [tr] [td]8815365[/td] [/tr] [tr] [td]8815410[/td] [/tr] [tr] [td]9013770[/td] [/tr] [tr] [td]9023719[/td] [/tr] [tr] [td]9082516[/td] [/tr] [tr] [td]9097149[/td] [/tr] [tr] [td]9178997[/td] [/tr] [tr] [td]9222934[/td] [/tr] [tr] [td]9254886[/td] [/tr] [tr] [td]9270248[/td] [/tr]
[/table][/td] [/tr]
[tr] [td]
Cat. # AB14W025150150 |
| Lot Numbers: |
| 8789931 |
| 8810473 |
| 8827208 |
| 8854221 |
| 8877645 |
| 8989919 |
| 9237414 |
[/left]
[/td] [td]
[tr] [td]Cat. # AB14W025210150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8744140[/td] [/tr] [tr] [td]8757219[/td] [/tr] [tr] [td]8826331[/td] [/tr] [tr] [td]8826333[/td] [/tr] [tr] [td]8826336[/td] [/tr] [tr] [td]9082532[/td] [/tr] [tr] [td]9155514[/td] [/tr] [tr] [td]9180316[/td] [/tr] [tr] [td]9209447[/td] [/tr] [tr] [td]9222907[/td] [/tr] [tr] [td]9233059[/td] [/tr] [tr] [td]9238795[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat. # AB14W030040150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8630847[/td] [/tr] [tr] [td]8703042[/td] [/tr] [tr] [td]8703044[/td] [/tr] [tr] [td]8703050[/td] [/tr] [tr] [td]8737491[/td] [/tr] [tr] [td]8741794[/td] [/tr] [tr] [td]8755622[/td] [/tr] [tr] [td]8789946[/td] [/tr] [tr] [td]8796008[/td] [/tr] [tr] [td]8841532[/td] [/tr] [tr] [td]8842327[/td] [/tr] [tr] [td]8847442[/td] [/tr] [tr] [td]8871667[/td] [/tr] [tr] [td]8916474[/td] [/tr] [tr] [td]8985601[/td] [/tr] [tr] [td]9217289[/td] [/tr] [tr] [td]9221183[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat. # AB14W030080150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8674379[/td] [/tr] [tr] [td]8710383[/td] [/tr] [tr] [td]8745612[/td] [/tr] [tr] [td]8757468[/td] [/tr] [tr] [td]8795994[/td] [/tr] [tr] [td]8816902[/td] [/tr] [tr] [td]8838736[/td] [/tr] [tr] [td]9153523[/td] [/tr] [tr] [td]9203512[/td] [/tr] [tr] [td]9221180[/td] [/tr] [tr] [td]9232658[/td] [/tr] [tr] [td]9237412[/td] [/tr]
[/table] [/td] [/tr] [tr] [td]
[tr] [td]Cat. # AB14W030120150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8711873[/td] [/tr] [tr] [td]8741781[/td] [/tr] [tr] [td]8755603[/td] [/tr] [tr] [td]8784854[/td] [/tr] [tr] [td]8792133[/td] [/tr] [tr] [td]8810472[/td] [/tr] [tr] [td]9023729[/td] [/tr] [tr] [td]9062683[/td] [/tr] [tr] [td]9097148[/td] [/tr] [tr] [td]9179000[/td] [/tr] [tr] [td]9224585[/td] [/tr] [tr] [td]9231360[/td] [/tr] [tr] [td]9248574[/td] [/tr] [tr] [td]9254782[/td] [/tr] [tr] [td]9286411[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W030150150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8741786[/td] [/tr] [tr] [td]8749899[/td] [/tr] [tr] [td]8789924[/td] [/tr] [tr] [td]8810474[/td] [/tr] [tr] [td]8836819[/td] [/tr] [tr] [td]8871664[/td] [/tr] [tr] [td]8970944[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W030210150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8815676[/td] [/tr] [tr] [td]8816203[/td] [/tr] [tr] [td]8816467[/td] [/tr] [tr] [td]8821338[/td] [/tr] [tr] [td]8821419[/td] [/tr] [tr] [td]8836748[/td] [/tr] [tr] [td]8847435[/td] [/tr] [tr] [td]9083740[/td] [/tr] [tr] [td]9148256[/td] [/tr] [tr] [td]9194250[/td] [/tr] [tr] [td]9216747[/td] [/tr] [tr] [td]9221182[/td] [/tr] [tr] [td]9235807[/td] [/tr] [tr] [td]9263491[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W035040150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8705822[/td] [/tr] [tr] [td]8784860[/td] [/tr] [tr] [td]8853567[/td] [/tr] [tr] [td]8989918[/td] [/tr]
[/table][/td] [/tr] [tr] [td]
[tr] [td]Cat.# AB14W035080150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8757061[/td] [/tr] [tr] [td]8815414[/td] [/tr] [tr] [td]9078466[/td] [/tr] [tr] [td]9248425[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W035120150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8703049[/td] [/tr] [tr] [td]8815409[/td] [/tr] [tr] [td]9078464[/td] [/tr] [tr] [td]9208441[/td] [/tr] [tr] [td]9286249[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W035150150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8822758[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W035210150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8789883[/td] [/tr] [tr] [td]8828189[/td] [/tr] [tr] [td]9208439[/td] [/tr] [tr] [td]9221817[/td] [/tr]
[/table][/td] [/tr] [tr] [td]
[tr] [td]Cat.# AB14W040040150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8629968[/td] [/tr] [tr] [td]8657024[/td] [/tr] [tr] [td]8755600[/td] [/tr] [tr] [td]8755601[/td] [/tr] [tr] [td]8755625[/td] [/tr] [tr] [td]8789935[/td] [/tr] [tr] [td]8821431[/td] [/tr] [tr] [td]8842537[/td] [/tr] [tr] [td]8877650[/td] [/tr] [tr] [td]8970943[/td] [/tr] [tr] [td]9209903[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W040080090[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]9220075[/td] [/tr] [tr] [td]9225648[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W040080150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8722279[/td] [/tr] [tr] [td]8749882[/td] [/tr] [tr] [td]8787509[/td] [/tr] [tr] [td]8822999[/td] [/tr] [tr] [td]9216848[/td] [/tr] [tr] [td]9224246[/td] [/tr] [tr] [td]9237413[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W040120150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8738444[/td] [/tr] [tr] [td]8749895[/td] [/tr] [tr] [td]8778810[/td] [/tr] [tr] [td]8789939[/td] [/tr] [tr] [td]8822880[/td] [/tr] [tr] [td]9000723[/td] [/tr] [tr] [td]9018516[/td] [/tr] [tr] [td]9097147[/td] [/tr] [tr] [td]9194251[/td] [/tr] [tr] [td]9204433[/td] [/tr] [tr] [td]9248553[/td] [/tr] [tr] [td]9263037[/td] [/tr] [tr] [td]9283623[/td] [/tr]
[/table][/td] [/tr] [tr] [td]
[tr] [td]Cat.# AB14W040210150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8741777[/td] [/tr] [tr] [td]8751214[/td] [/tr] [tr] [td]8784853[/td] [/tr] [tr] [td]8810467[/td] [/tr] [tr] [td]8822411[/td] [/tr] [tr] [td]8836749[/td] [/tr] [tr] [td]9235780[/td] [/tr] [tr] [td]9245449[/td] [/tr]
[/table][/td] [td]
[tr] [td]Cat.# AB14W040150150[/td] [/tr] [tr] [td]Lot Numbers:[/td] [/tr] [tr] [td]8747184[/td] [/tr] [tr] [td]8796001[/td] [/tr] [tr] [td]8837761[/td] [/tr] [tr] [td]8873813[/td] [/tr]
[/table][/td] [td] [/td] [td] [/td] [/tr] [/table] 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.
Source: Food and Drug Administration--Recalls/Safety Alerts
