A device used on heart patients during angioplasty procedures is being recalled by the Food and Drug Administration (FDA) because of a design defect that may cause life-threatening injuries. The Class 1 recall involves the AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018″ Platform. A Class 1 recall the most severe type of recall the Food and Drug Administration (FDA) can give, and is reserved for drugs or devices in which there is a potential for serious injury or death.

Angioplasties are procedures used to reduce blockages within arteries. When an angioplasty is performed, the doctor uses a catheter with a deflated balloon attached. The catheter is passed across the narrowest portion of the artery and then the balloon is expanded. The balloon compresses the plaque that is causing the blockage. When the balloon is deflated and removed, the plaque remains but is compressed, thus reducing the blockage. 

The AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter was found to have defects that caused unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. The FDA warns that use of the affected devices may lead to retained device fragments or significant arterial injury that may lead to death, or the need for additional surgical intervention.

AngioScore Inc. is advising its customers to immediately discontinue use of the product, examine their inventory, and quarantine all affected products. Any serious side effects with this or any other device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.