Cordis Dura Star™ RX, Fire Star™ RX PTCA Balloon Catheters recall due to deflation problems

Cordis Corporation and FDA informed healthcare 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 used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels 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.

For more information about this topic click on the following FDA Medical Device Recall Article: Class 1 Recall: Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters