Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters

Valve Replacement Forums

Help Support Valve Replacement Forums:

This site may earn a commission from merchant affiliate links, including eBay, Amazon, and others.

Ross

Well-known member
Joined
Dec 15, 2001
Messages
25,981
Location
On The Hot Seat
Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters

Audience: Cardiovascular healthcare professionals, hospital risk managers
[Posted 01/25/2008] 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.

[January 25, 2008 - Recall Notice - FDA]
 

Latest posts

Back
Top