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U.S. Department of Health and Human Services

Safety

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Boston Scientific Mach 1 Guide Catheters

Audience: Hospital risk managers, cardiovascular healthcare professionals

[Posted 12/22/2006] Boston Scientific Corporation and FDA informed healthcare professionals of a recall of 12 lots of Mach 1 Guide Catheters, used to deliver medical devices to the heart to treat coronary artery diesease. The affected product was distributed to hospitals in the United States. Some product units of the affected lots may contain excess strands of resin in the inner lumen near the hub of the guide catheter. If excess resin is present in the catheter and detaches during a procedure, there is the potential for embolization. If an obstruction occurs in a major blood vessel or multiple small blood vessels, it may result in serious complications such as stroke, heart attack or kidney problems.

[December 15, 2006 - Press Release - Boston Scientific]