J&J recalls Star, Dura Star balloon catheters-FDA

Fri Jan 25, 2008 12:25pm EST
 
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CHICAGO, Jan 25 (Reuters) - Johnson & Johnson (JNJ.N) recalled its Fire Star-RX and Dura Star-RX PTCA balloon catheters used for angioplasty, according to a notice posted on the U.S. Food and Drug Administration's Web site on Friday.

The recall, initiated on Jan. 14, 2008, was classified as a Class 1 recall, the most serious type, involving situations in which there is a reasonable probability the use of the product will cause serious injury or death, the FDA said.

"The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels," the FDA said.

"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," it said.

No one from from the company was immediately available to comment. (Reporting by Debra Sherman; Editing by Brian Moss)

 

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