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Boston Scientific Japan Voluntarily Recalls Imported Catheters

This article was originally published in PharmAsia News

Executive Summary

Tokyo Metropolitan government announced April 30 that major U.S. medical device maker Boston Scientific's Japanese subsidiary has started voluntarily recalling a total of 13,647 imported catheters used for angioplasties to expand narrowed coronary arteries. A total of 597 medical facilities nationwide will be impacted by the recall. According to the Tokyo government, the main concern for the recall is due to the Cutting Balloon Ultra, made in Ireland. Due to a production error, the balloon either does not shrink, or takes longer than usual to shrink. In Japan, two such cases have been reported; however, no health damage was noted. (Click here for more - Japanese language) "13600 Imported Catheters Get Recalled For Quality Concerns" - Jiji Press News (4/30/08)



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