Heart Catheters Recalled due to Death Risk

January 2008

Urgent alert – Johnson & Johnson has issued a recall of 132,000 of its Cordis balloon catheters. The devices, which were used nationwide in angioplasties, can potentially cause fatal injuries.

The Fire Star-RX and Dura Star-RX PTCA catheters have a potential for slow deflation or no deflation when inserted into a blood vessel or other artery, leading to total blockage of that artery or vessel. This blockage can result 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.

The catheters were distributed in the United States in August 2007. All Fire Star and Dura Star catheters in lots 13173912 through 13315455 have been recalled. Additionally, 52 lots above 13315455 are affected. Two injuries have been reported.