The <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">ev3 NanoCross .014″ OTW PTA Dilatation Catheter has been named in a Class I recall because the medical device has the potential to crack or break, the U.S. Food and Drug Administration (FDA) just announced.
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.
There is potential for cracking or breaking during use.Â 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.
The NanoCross 0.014â€ OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries.Â 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.
In a letter dated November 10, 2010, ev3 notified healthcare facilities of the NanoCross .014â€ OTW PTA Dilatation Cathetersâ€™ voluntary recall. In this letter, it was requested that all affected products be located and removed from use. Detailed steps were also provided about the return and disposition of these affected products to ev3.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Â· Complete and submit the report online: www.fda.gov/MedWatch/report.htm
Â· Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178