The Food and Drug Administration (FDA) has issued a Class I recall on sheaths that are inserted in blood vessels because there is a risk the sheath tip could break off in the body and lead to serious, life-threatening complications. Class I recalls are the most severe type of FDA recall and are only issued when the there is a potential for serious injury or death.
Thomas Medical Products Inc., announced it is recalling its Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport. The sheaths are tube-like devices placed into blood vessels. Pacing or defibrillator wires and catheters are placed through the sheaths to easily insert them into blood vessels. The sheaths are being recalled because the 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, including the lungs, heart or, less commonly, the arteries. From there, the broken tip could cause a blockage anywhere, including the brain or heart, leading to permanent injury, including stroke or heart attack, or even death.
To date, the manufacturer has received 38 reports of adverse events in which the sheath tip became separated.
The sheaths were manufactured and distributed from December 1, 2005 through December 1, 2009. Customers with questions may contact Thomas Medical Products at 1-866-466-3303, Monday through Friday from 8:30 a.m. until 5 p.m. eastern time, or e-mail the company at firstname.lastname@example.org.