Class I Recall for SafeSheath Device

Thomas Medical Products (TMP) formally announced a worldwide voluntary recall of the <"">SafeSheath® CSG® Sheath Introducer the U.S. Food and Drug Administration (FDA), just announced. The defect involves reported fragmentation and embolization of the radiopaque (RO) soft tip during use due to material degradation.

The SafeSheath® CSG® Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport recall is a Class I. Class I recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

TMP explained that the recalled SafeSheath® CSG® Sheath Introducer is a hemostatic introducer system with infusion side port intended for the introduction of various types of pacing or defibrillator leads. The FDA explained that sheaths are tube-like devices placed into blood vessels. Pacing or defibrillator wires and catheters are placed through sheaths to easily insert them into blood vessels.

The recalled product was developed and manufactured by Thomas Medical Products, Inc. TMP is located at 65 Great Valley Parkway, Malvern, Pennsylvania, 19355-1302. The recalled product was distributed by Pressure Products, Inc. (PPI), which is located at 1861 N. Gaffey Street, Suite B,
San Pedro, California, 90731.

The FDA noted that 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. To date, TMP has received 38 adverse event reports in which the SafeSheath® CSG® Introducer Tip became separated. According to TMP, this recall is intended to minimize future occurrences and adverse events.

TMP and PPI are notifying all customers about this recall through notices sent to each customer and are also arranging for return of all unused products. Customers with questions may contact TMP at 1-866-466-3003 between the hours of 8:30 AM to 5:00 PM Eastern Standard Time, or by email at,

The recall encompasses products distributed from December 1, 2005 to December 14, 2009. A complete list of lot ranges and catalog numbers can be accessed at:

This entry was posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.