ev3 Initiates Voluntary Recall of Specific Lots of NanoCross™ .014" OTW PTA Dilatation Catheter
Date of Recall
2010-12-28Recall Details
- Plymouth, MN - December 15, 2010 - 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, 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.
Affected ev3 NanoCross™ .014" OTW PTA Dilatation Catheter Product Catalog / Lot Numbers
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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
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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: 1-800-332-0178
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Phone: 1-800-332-1088
Recall Comments
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