Arterial Problems from Catheter Cause FDA to Issue a Class I Recall for Catheters by AngioScore

A catheter recall has been issued by the FDA for the AngioSculpt Percutaneous Translumenal Angioplasty Scoring Balloon Catheter OTW 0.018" Platform. The catheter is commonly used for the treatment of peripheral artery disease. The recalled catheter poses the potential threat of breaking due to a design defect that may result in peeling of the bond or detachment of the distal end of the score element.

The FDA has advised healthcare providers to stop use of the product immediately.

The defect can be potentially fatal due to the fact that it may result in fragments of the catheter being left in a patient or may result in significant arterial damage. Either of these issues can cause death or cause the need for surgery to remove the dangerous particals.

The FDA gave this recall a Class I because there is reasonable chance of serious adverse health consequences or death with the continued use of this product.

If you or a loved one were affected by this catheter recall contact Frank J. Dito Jr. Staten Island injury lawyer for additional information on your rights against the manufacturer of the catheters. Call 718-979-4300 or fill out our contact form for immediate help.