| Subject: | FDA and Boston Scientific Announce Recall of Mach 1 Guide Catheters |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 29 Dec 2006 - 12:00 am |
| The FDA and Boston Scientific Corporation has announced a recall of 12 lots of Mach 1 Guide Catheters, used to deliver medical devices to the heart to treat coronary artery disease. 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... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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