On February 4, 2010, the U.S. Food and Drug Administration (FDA) and Thomas Medical Products Inc. notified health care professionals of a Class I Recall of certain lots of Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, such as a stroke or heart attack, or even death.

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online with the MedWatch Online Voluntary Reporting Form), by phone 1 (800) 332-1088 or fax 1 (800) FDA-0178. Individuals can also report  adverse events to the FDA by returning the postage-paid FDA form 3500 (obtain forms by visiting the FDA's Download Forms web page) and mailing the form to the address on the pre-addressed form.

Read the complete MedWatch 2010 Safety summary, which includes a link to the FDA recall notice.