Cordis recalls balloon catheters.Cordis and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. informed health care professionals of a Class I recall of all Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are use in a medical procedure (known as percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is or PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ) to open narrowe or blocked blood vessels Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death. Read the complete MedWatch 2008 safety summary, including a link to the recall notice, at http://www.fda.gov/medwatch/safety/2008/safety08.htm#DuraStar |
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