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Class I Medical Device Recall: AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter

Posted Sep 07 2010 9:00pm

Recall Class: Class I

Date Recall Initiated: December 4, 2009

Product: AngioSculpt "EX" Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter (all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003).

This recall only includes "EX" Catheters.

This product was distributed from January 30, 2009 through December 4, 2009.

Use: 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).

Recalling Firm:
AngioScore Inc.
5055 Brandin Court
Fremont, California 94538

Reason for Recall: The PTCA catheters may become separated during use in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death.

Public Contact: Customers may contact AngioScore Customer Service at 1-877-264-4692.

FDA District: San Francisco

FDA Comments:

On December 4, 2009, the company sent its customers a recall notice addressed to Catheterization Laboratory Managers. The recall notice instructed the Catheterization Laboratory Managers 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.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

    
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