Safesheath System Recall

On December 17, 2009, Thomas Medical Products, Inc. announced a Class I recall for the Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport, used in blood vessels to guide defibrillator wires and catheters.

The recalled Safesheath products have a tip that may break off and separate while the sheath is inside a blood vessel. A broken tip may move through the vessel into the lungs, heart, or arteries, causing a blockage leading to permanent injury, such as a stroke or heart attack, or even death.

The recall affects products manufactured and distributed from December 1, 2005 through December 1, 2009.

The company instructs all distributors and consumers to stop using these sheaths immediately and return all unused devices. Customers may contact Thomas Medical Products at 1-866-466-3303.

 

Sources:

  1. http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm199918.htm