Recall Issued for AngioSculpt PTCA Scoring Balloon Catheters

Washington, DC: The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters are being recalled because they may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.

This recall includes all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003. This product was distributed from January 30, 2009 through December 4, 2009.

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).

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Published on Sep-8-10