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Class I Recall Issued for AngioSculpt Balloon Catheters

Sep 9, 2010 | Parker Waichman LLP

AngioScore Inc.’s AngioSculpt’s EX Percutaneous Transluminal Coronary Angioplasty (PTCA) scoring balloon catheters are subject to a Class I recall. According to the recall notice, the catheters may fragment and become lodged in a patient’s coronary arteries, resulting in serious injuries and even death.

Class 1 recalls are the Food & Drug Administration’s (FDA) most serious type of recall and involve situations in which there is a reasonable probability that use of a device will cause serious adverse health consequences or death.

The AngioSculpt PTCA Scoring Balloon Catheter is used to dilate narrowed coronary arteries (stenosis), and to improve blood flow to the heart muscle (myocardial perfusion).

This recall involves all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003. The AngioSculpt PTCA Scoring Balloon Catheters distributed from January 30, 2009 through December 4, 2009.

On December 4, 2009, AngioScore sent its customers a recall notice addressed to Catheterization Laboratory Managers instructing them to inspect their inventory for this recalled product from the involved lot, and separate it from their inventory. The managers were also asked to record all the affected products and to FAX the return forms to the company.

AngioScore Customer Service has contacted its customers and provided instructions for the return and replacement of the affected product. Customers may contact the company at 1-877-264-4692.


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