FDA and Thomas Medical Products Inc. notified healthcare professionals of a Class I Recall of certain lots of the product, 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 [at www.fda.gov/MedWatch/report.htm], by phone 1-800-332-1088, or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch “Download Forms” page] by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
