FDA Recalls Hemostatic Introducer System

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The U.S. Food and Drug Administration has issued a Class I recall for specific lots of  Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport made by Thomas Medical Products Inc. The tube-like medical device, placed in blood vessels, inserts pacing or defibrillator wires and catheters into blood vessels. The sheath tip could break off, separate inside a blood vessel, and move through the vessel into organs such as the lungs, heart, or less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart. This could lead to a debilitating injury such as stroke, heart attack or death.

Any related adverse events with the SafeSheath® CSG® Sheath Introducer should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.htm, by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [downloaded from the MedWatch “Download Forms” page], by mail to address on the pre-addressed form, or fax 1-800-FDA-0178.