The FDA has issued a Class I recall of AngioSculpt’s EX Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheters, after it was found that the devices may fragment and become lodged in a patient’s coronary arteries, resulting in serious injuries and even death.
AngioSculpt initially sent a letter on Dec. 4, 2009, to notify customers who purchased its scoring balloon catheters with REF numbers 2034-XXYY and lot numbers less than F0906003 and distributed between Jan. 30, 2009, and Dec. 4, 2009. However, the agency only issued its Class 1 recall designation Sept 8. "Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA.
EX PTCA catheters are used to dilate coronary artery stenosis and work to improve blood flow to the heart.
The FDA recommends that customers inspect cath lab inventory and report any adverse events or side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.