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Nipro Recalls Balloon Catheters In Japan

This article was originally published in PharmAsia News

Executive Summary

Japanese major medical device maker, Osaka-based Nipro, announced a recall of two kinds of balloon catheters (totaling 5,680 devices). The reason for the recall is insufficient strength and the concern that air might get into the blood vessels. Last November, a case in which air got into a patient's blood vessels was reported in Japan. The patient later recovered through medical treatment. A loose connection between the air ball and catheter was highly suspected as a cause in that case. The two types of catheter under recall are the Sidekick and Gimlet , made between November 2006 and August 2007. A total of 247 medical facilities in Japan will be impacted by the recall. (Click here for more-Japanese language

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