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Fire Star and Dura Star Balloon Catheters

Fire Star and Dura Star Balloon Catheters were recalled by the FDA on January 14, 2008. The recall is a Class I recall, which are the most serious types of recalls and means there is reasonable probability that using the device will result in injury or death.

Balloon catheters are used to open narrowed or blocked blood vessels and heart arteries. The Fire Star and Dura Star balloon catheters either do not deflate or deflate too slowly when inserted, resulting in a total blockage of blood vessels.
 
This can cause heart arrhythmia, heart artery damage, heart attack, or death. Some patients require further surgery to remove the catheter.
 
The catheters were manufactured in Mexico in 2007 and distributed in 2007 and 2008. All Fire Star and Dura Star models were affected. If you were injured by a Fire Star or Dura Star Balloon Catheter or if you required extra surgery to remove the device, contact a personal injury attorney immediately.
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