Cordis Dura Star™ RX, Fire Star™ RX PTCA Balloon Catheters Recalled
The FDA announced a Class I recall of Cordis balloon catheters on January 18, 2008 due to the risk that the balloon may either slowly deflate, or not deflate at all after insertion for angioplasty.
If the angioplasty balloon does not properly deflate, it may result in a total blockage of the artery. A blocked artery may cause:
- A change in heart rate
- A change in heart rhythm
- Injury to the artery
- Heart attack
A faulty angioplasty balloon may require surgery, or result in death. The lots affected by the recall are all Dura Star™ and Fire Star™ 13173912 through 13315455. In addition, 52 lots above 13315455 are affected. No lots above 13329055 are affected. The Cordis balloon catheters are used during angioplasty, when a balloon is inserted in order to open a narrowed or blocked artery in the heart.
The Cordis balloon catheters were recalled by the FDA as a Class I. A Class I recall is the most serious type of recall, as it pertains to situations where there is a probability that the product may cause serious injury or death.
If you or a loved one has sustained serious or fatal injuries due to Cordis Dura Star™ RX, Fire Star™ RX PTCA balloon catheters, contact a Cordis balloon catheter attorney at Cappolino Dodd Krebs LLP at 1-800-460-0606. An experienced Cordis balloon catheter lawyer will be able to evaluate if you are eligible to seek compensation.