Angioplasty Catheter Recall: Defective Design Could Cause Death

More than 17,000 AngioScore Inc. angioplasty balloon catheters have been recalled due to a defective design that may allow them fracture and peel, which could lead to injury or death. 

The FDA announced the AngioScore catheter recall on Wednesday, after it was discovered that a design defect caused unintended fracturing and peeling. This results in peeling of the bond and detachment from the scoring element.

The FDA warns that use of the devices could cause fragments to be left behind in the patient’s body, or could lead to significant injury to arteries, additional surgeries or death. The catheter recall is classified as a Class I medical device recall, meaning the FDA has determined that use of the devices has the reasonable possibility of causing severe injury or death. However, no significant injuries or deaths have been reported at this time.

The recall affects 17,682 units of the AngioSculpt PTA Scoring Balloon Catheter OTW 0.018” Platform. They are used to dilate lesions in arteries and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The recall includes all sizes and lot codes of model numbers 2076-4020, 2076-5020, 2076-6020, 2092-6020, and 2105-6020. The devices were distributed from September 2007 to November 2010.

AngioScore Inc. has notified customers by mail. The company is advising customers to immediately stop using the catheters, examine their inventory for any affected units and quarantine them. The company has provided inventory forms to customers with instructions on how to return the units. Any customers with questions should call AngioScore Customer Service at 1-877-264-4692.