Balloon catheter recall issued for devices used during PTCA

Johnson & Johnson has issued a world-wide balloon catheter recall for a medical device used to open blocked blood vessels during a heart procedure known as PTCA, or percutaneous transluminal coronary angioplasty. The defective balloon catheters could fail to properly function, leading to a risk of serious injury or death.

The balloon catheter recall applies to about 132,000 of the “Dura Star RX” and “Fire Star RX PTCA” balloon catheters made by Cordis Corporation, a subsidiary of Johnson & Johnson. Approximately 57,000 of the devices were sold in the United States, and the manufacturer indicates that they were distributed between March 26, 2007 and January 8, 2008.

The recall has been classified by the FDA as a class 1 recall, since use of the defective balloon catheters poses a reasonable probability of serious injury or death. Once the balloon catheter is inserted into the heart artery or blood vessel, it may deflate slower than it is supposed to or not deflate at all. This could lead to a total blockage of the artery, which may injure the artery or change the heart rate or rhythm. The balloon catheter defects could also lead to a heart attack, additional surgical procedures or death.

BALLOON CATHETER LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have been injured by a defective balloon catheter used during a PTCA, or percutaneous tranluminal coronary angioplasty, to open a narrowed artery or blood vessel. If you, a friend or family member have suffered a heart attack, additional surgical procedures, death or other serious injury during an angioplasty procedure performed since March 26, 2007, request a free consultation.