The FDA has issued a Class I recall of AngioSculpt PTA Scoring Balloon Catheters sold between September of 2007 and November of 2010, noting that they pose a risk of serious injury or death from a design flaw which could result in “unintended fracture or peeling.”
More than 17,000 units have been recalled by AngioScore Inc., the manufacturer of the defective catheters. The company distributed letters to its U.S. customers on November 15, 2010, listing the reason for the recall as “potential harm to patients,” reports the FDA. All sizes and lots of the following model numbers are included in the recall: 2076-4020, 2076-5020, 2076-6020, 2092-6020, and 2105-6020.
An angioplasty involves the insertion of an empty balloon-like tube, known as a balloon catheter, into a blood vessel. The catheter is then inflated with water, widening the vessel, crushing obstructions, and improving blood flow. The defective AngioSculpt catheters may break or peel during use, the FDA says, possibly damaging the blood vessels or even leaving fragments of the catheter behind after it is removed. The recall notice explains that if this happens, additional surgical intervention may be necessary.
A Class I is the most serious type of recall, indicating that “the use of these products will cause serious adverse health consequences or death,” according to the report. Though no deaths or severe injuries from using these catheters have been reported, in addition to immediately ceasing use of the product, the FDA advises customers to “examine their inventory, and quarantine all affected product.” Customers can contact AngioScore Inc. at (877) 264-4692 for an inventory form to return the product or if they have questions about the recall.
Angioplasties are performed on patients who have significant blockage in one or more arteries, usually due to coronary artery disease. According to WebMD, the procedure is non-surgical, usually performed by a cardiologist, and lasts about one and a half to two and a half hours, though the recovery time may require several hours after that. The FDA notes that the AngioSculpt catheter can be used in arteries in the thigh, groin, abdomen, or knee “for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.”
U.S. Food and Drug Administration. (January 5, 2011) “AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon CatheterOTW 0.018” Platform (multiple sizes).” Retrieved on January 7, 2011 from the FDA.
WebMD. (2009) “Heart Disease Treatment with Angioplasty and Stents” Retrieved on January 7, 2011 from WebMD.